BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Report
- Report Number
- 9610847-2018-00111
- Event Type
- Malfunction
- Date Received
- May 7, 2018
- Date of Event
- April 13, 2018
- Report Date
- September 4, 2018
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 30382903851004
- PMA / PMN Number
- K013621
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
H.6. INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW: 7220530; WAS BUILT ON QFA LINE3, FROM AUGUST 10, 2017 THRU AUGUST 11, 2017. 7220533; WAS BUILT ON QFA LINE 3, FROM AUGUST 13, 2017 THRU AUGUST 17, 2017. 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, ALL THE 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. THE PEURA (END USER RISK ANALYSIS): YES REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5699 REV 5 VERSION D WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. VISUAL ANALYSIS OBSERVATIONS AND TESTING: RECEIVED ONE USED Q-SYTE UNIT IN AN OPENED PACKAGE FROM THE LOT NUMBER 7235538. VISUAL/MICROSCOPIC EXAMINATION: THE Q-SYTE TOP AND BOTTOM BODIES WERE SEPARATED AT THE WELD JOINT LINE. THERE WAS EVIDENCE OF AN ADEQUATE WELD LINE BETWEEN THE TOP AND BOTTOM BODIES. INVESTIGATION CONCLUSION: ROOT CAUSE RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE ¿ A DEFINITE CAUSE OF THE WELD JOINT SEPARATION COULD NOT BE ESTABLISHED; THERE WAS EVIDENCE OF AN ADEQUATE WELD LINE. THIS IS AN INDICATION THAT A BOND (WELD) WAS PROVIDED DURING THE MANUFACTURING PROCESS. COMMENT: AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY.
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: SEX: UNKNOWN. EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES.
IT WAS REPORTED THAT WHILE USING A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, THE DEVICE WAS UNABLE/DIFFICULT TO BE REMOVED FROM THE SYRINGE BEING USED FOR SAMPLING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT WHILE USING A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, THE DEVICE WAS UNABLE/DIFFICULT TO BE REMOVED FROM THE SYRINGE BEING USED FOR SAMPLING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER FAX #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USING A BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE, THE DEVICE WAS UNABLE/DIFFICULT TO BE REMOVED FROM THE SYRINGE BEING USED FOR SAMPLING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335715 | BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE | LUER ACCESS SPLIT SEPTUM | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 7334848 | 30382903851004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |