BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE
Report
- Report Number
- 9610847-2018-00126
- Event Type
- Malfunction
- Date Received
- May 15, 2018
- Date of Event
- April 21, 2018
- Report Date
- August 23, 2018
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 00382903851003
- PMA / PMN Number
- K013621
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: MDR; REVIEW WAS CONDUCTED ON THE Q-SYTE SUB-ASSEMBLY LOT NUMBERS ASSOCIATED WITH THE OPENED PACKAGE (PART # 385100-LOT 7242779) PROVIDED WITH THIS INCIDENT, WHICH DISCLOSED THE FOLLOWING: (SUB-ASSEMBLY PART # 8001498 / LOT #S 77227575, 7227576 AND 7234812) . LOT #S 7227575; WAS BUILT ON QFA LINE #3, FROM 18AUG2017 THRU 20AUG2017 FOR THE QUANTITY OF (B)(4)EA. LOT #S 7227576; WAS BUILT ON QFA LINE #3, FROM 20AUG2017 THRU 21AUG2017 FOR THE QUANTITY OF (B)(4)EA. LOT #S 7234812; WAS BUILT ON QFA LINE #2, FROM 26AUG2017 THRU 28AUG2017 FOR THE QUANTITY OF (B)(4)EA. REVIEW OF THE DHRS DISCLOSED NO INDICATION OF THE ALLEGED DEFECT, AS THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOTS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT AS STATED IN THE PIR. PER REVIEW OF THE DHRS IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. SET-UP AND IN-PROCESS SAMPLES (INCLUDING BUT NOT LIMITED) BOND/WELD STRENGTH AND LEAK TESTING WERE PERFORMED THROUGHOUT THE PROCESS, INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE DISCLOSED AS IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THESE LOTS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SAP (QN) DATABASE REVIEW: THIS INCIDENT WAS AN S1 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THIS MDR-LEVEL A INVESTIGATION FOR THE Q-SYTE SUB-ASSEMBLY LOT NUMBERS ASSOCIATED WITH THE OPENED PACKAGE (PART # 385100-LOT 7242779) PROVIDED WITH THIS INCIDENT. THE REVIEWS DISCLOSED THAT THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE ALLEGED DEFECT ASSOCIATED WITH THE SUB-ASSEMBLY LOT NUMBERS FOR THIS INCIDENT. ANALYSIS OF PEURA AND/OR FMEA CONDUCTED BY QE: Q-SYTE: THE PEURA (END USER RISK ANALYSIS) RM5699 V.5 (D) WAS REVIEWED AND IT WAS CONFIRMED THAT THE FAILURE MODES ARE IDENTIFIED. IN ADDITION, THE RISK IS ACCEPTABLE GIVEN A LOW OCCURRENCE. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: IN ADDITION TO A PREVIOUS PHOTO THAT WAS PROVIDED FOR EVALUATION OF THIS INCIDENT, WE HAVE NOW RECEIVED AN UNUSED Q-SYTE UNIT WITHIN AN OPENED PACKAGE FROM LOT 7242779. ACCOMPANYING THE RETURNED Q-SYTE WERE TWO MISCELLANEOUS EXTENSION LINES. THE Q-SYTE UNIT HAD THE BLUE DUST CAP ATTACHED AND WAS INTACT. VISUAL ASSESSMENT: OF UNIT: UNIT WAS OBSERVED TO BE OF A 32 CAVITY MOLD. THERE WERE NO VISIBLE ANOMALIES OR DAMAGE OBSERVED TO ANY OF THE EXTERNAL AREAS OF THE RETURNED Q-SYTE UNIT. OBSERVED THE SLIT AT THE SEPTUM TOP DISK WAS PRESENT AN IN THE CORRECT POSITION (CENTERED) AND THERE WAS NO DAMAGE TO THE SLIT OR THE FACE OF THE DISK. FUNCTIONAL TEST (CONNECTION COMPATIBILITY): A FUNCTIONAL ASSESSMENT OF THE CONNECTION COMPATIBILITY OF THE RETURNED Q-SYTE UNIT USING THE ACCOMPANIED MISCELLANEOUS EXTENSION LINES AND A LABORATORY PROVIDED BD ISO STANDARD MALE LUER SYRINGE WAS CONDUCTED. MISCELLANEOUS EXTENSION LINES; THE CONNECTION OF THE RETURNED Q-SYTE UNIT TO THE ACCOMPANIED 2 EXTENSION LINES WAS SUCCESSFUL. DURING THE CONNECTION THE Q-SYTE TIGHTEN COMPLETELY AND REMAIN INTACT UNTIL PHYSICALLY LOOSENED AND REMOVED. LABORATORY PROVIDED BD ISO STANDARD MALE LUER SYRINGE; CONNECTION OF THE Q-SYTE TO THE BD ISO STANDARD LUER LOCK SYRINGE WAS SUCCESSFUL. NOTE: THE RETURNED Q-SYTE UNIT STAYED CONNECTED (NO DISCONNECTION) DURING TESTING. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO: THE Q-SYTE UNIT PROVIDED FOR THIS INCIDENT DID NOT REVEAL ANY ANOMALIES OR DAMAGE AND DID NOT DEMONSTRATED DETACHMENT WHEN TESTED. THE CORRECTIVE ACTION STATEMENT IS APPROVED / AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY THE DESIGNATED COMPLAINT HANDLING UNIT (DCHU). DEVICE/BATCH HISTORY RECORD REVIEW: MDR; REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER PROVIDED WAS AN INVALID LOT NUMBER. SAP (QN) DATABASE REVIEW: NO REASON: THIS DATABASE TRACKS ANY ISSUE DURING PRODUCTION THAT WOULD AFFECT PRODUCT QUALITY FINDINGS: THIS INCIDENT WAS AN S1 SEVERITY RANKING. REVIEW WAS NOT CONDUCTED FOR THIS MDR-LEVEL A INVESTIGATION BECAUSE A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. INVESTIGATION CONCLUSION: ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE ¿ AN EVALUATION OF THE RETURNED Q-SYTE UNIT DID NOT REVEAL ANY QUALITY ISSUES THAT WOULD CONTRIBUTE TO INCOMPATIBILITY OF ATTACHMENT OR LOOSENING; THEREFORE THE DEFECT COULD NOT BE IDENTIFIED AND ROOT CAUSE COULD NOT BE DETERMINED. COMMENT: NOTE: THE Q-SYTE IS MANUFACTURED TO AN ISO STANDARD AND IS INTENDED FOR USE WITH ISO COMPLIANT DEVICES. PER THE IFU: GENERAL GUIDELINES THE BD Q-SYTE IS INTENDED FOR USE ONLY WITH THE FOLLOWING: INTRAVASCULAR LINES. ISO LUER-SLIP AND LUER-LOCK CONNECTORS ON STANDARD IV ADMINISTRATION SETS, EXTENSION SETS, AND SYRINGES. CAUTION AND WARNING: LUER SLIP CONNECTIONS SHOULD NOT BE LEFT UNATTENDED, DUE TO THE POTENTIAL FOR DISCONNECTION (SEE Q-SYTE IFU FOR THE DETAILS).
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES. DEVICE EVAL BY MANUFACTURER? YES. METHOD CODE: 4101 CHANGED TO 4103.
IT WAS REPORTED THERE WERE CONCERNS WHEN USING BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICES AS THEY REPORTEDLY "DISCONNECT BETWEEN THE Q SYTE LUERS AND IV GIVING SETS." THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THERE WERE CONCERNS WHEN USING BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICES AS THEY REPORTEDLY "DISCONNECT BETWEEN THE Q SYTE LUERS AND IV GIVING SETS." THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THERE WERE CONCERNS WHEN USING BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICES AS THEY REPORTEDLY "DISCONNECT BETWEEN THE Q SYTE LUERS AND IV GIVING SETS." THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359305 | BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE | LUER ACCESS SPLIT SEPTUM | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | UNKNOWN | 00382903851003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |