BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
Report
- Report Number
- 9610847-2018-00186
- Event Type
- Malfunction
- Date Received
- June 7, 2018
- Date of Event
- May 28, 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
- CH
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEWS WERE PREVIOUSLY CONDUCTED ON THE TWO ASSOCIATED SUB-ASSEMBLY (Q-SYTE) LOT NUMBERS FOR PR 199699-211451 CR, WHICH DISCLOSED THE FOLLOWING: LOT 6336638; WAS BUILT ON QFA LINE 4, FROM DECEMBER 3, 2016 THRU DECEMBER 5, 2016. LOT 6334750; WAS BUILT ON QFA LINE 3, FROM NOVEMBER 30, 2016 THRU DECEMBER 2, 2016. PER REVIEW OF THE DHRS IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SAP (QN) DATABASE REVIEW FINDINGS: THIS INCIDENT WAS AN S1 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THIS MDR-LEVEL A INVESTIGATION FOR THE Q-SYTE SUB-ASSEMBLY LOT NUMBERS. THE REVIEWS DISCLOSED; THERE WAS 1 POTENTIALLY RELATED QN INITIATED DURING THE BUILD OF LOT 6336638 AND NO REJECT ACTIVITY FINDINGS THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT ASSOCIATED WITH THE SUB-ASSEMBLY LOT 6334750 FOR THIS INCIDENT. THE PEURA (END USER RISK ANALYSIS) WAS REVIEWED AND IT WAS CONFIRMED THAT THE FAILURE MODES ARE IDENTIFIED. IN ADDITION, THE RISK IS ACCEPTABLE GIVEN A LOW OCCURRENCE. OBSERVATIONS AND TESTING: RECEIVED FOUR USED Q-SYTE UNITS WITHOUT PACKAGING: UNITS 1 WAS ALONE WITHOUT ANY ATTACHMENTS. UNIT 2 HAD A MISCELLANEOUS CAP ATTACHED TO THE MALE LUER END. UNIT 3 HAD A MISCELLANEOUS EXTENSION LINE AT ATTACHED TO THE MALE LUER END WHERE THE MALE LUER WAS BROKEN AND THE EXTENSION LINE WAS CUT. UNIT 4 WAS ATTACHED TO A MISCELLANEOUS SYRINGE. ALL FOUR Q-SYTE UNITS HAD TRACES OF DRIED MEDIA/MEDS. VISUAL/MICROSCOPIC EXAMINATION: UNITS 1, 2 AND 4 WERE FROM MOLD CAVITY 32. THERE IS NO DAMAGE TO THE TOP OR BOTTOM BODY (POLYCARBONATE OR TO THE SEPTUM TOP DISK OF THE SEPTUM (POLYCARBONATE) OF THE Q-SYTE. UNITS 1: THE SEPTUM TOP DISK WAS LIFTED FROM THE TOP BODY AND HAD A LARGE JAGGED TEAR IN THE COLUMN WALL. RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS WERE OBSERVED ON THE RIM OF THE TOP BODY (POLYCARBONATE) AND TOP DISK OF THE Q-SYTE UNIT. CONFIRMED THERE WAS EVIDENCE OF RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS ON THE RIM OF THE TOP BODY; INDICATING A SUFFICIENT BOND AT TIME OF MANUFACTURE. UNIT 2: THE SEPTUM TOP DISK WAS LIFTED FROM THE TOP BODY. RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS WERE OBSERVED ON THE RIM OF THE TOP BODY (POLYCARBONATE) AND TOP DISK OF THE Q-SYTE UNIT. CONFIRMED THERE WAS EVIDENCE OF RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS ON THE RIM OF THE TOP BODY; INDICATING A SUFFICIENT BOND AT TIME OF MANUFACTURE. UNIT 3: OBSERVED A TEAR/BREAK OF THE SEPTUM; TOP DISK AND A PORTION OF THE COLUMN WALL TORN AWAY AT THE COLUMN WALL FROM THE BOTTOM DISK. OBSERVED THE LUER AND RIM OF THE TOP BODY WERE BROKEN. THE JAGGED BREAK OF THE LUER AND TOP BODY (POLYCARBONATE) WAS INDICATIVE OF BREAK BY EXTREME STRESS. UNIT 4: NO ANOMALIES OR DAMAGE WERE OBSERVED TO THE Q-SYTE UNIT. THE FINDINGS IN THIS INCIDENT WERE INDICATIVE THAT THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS FOR THE DAMAGE/FAILURE OBSERVED, AS THE DAMAGE OBSERVED WAS CAUSE BY EXTREME STRESS. CONCLUSIONS: CONFIRMATION OF THE FAILURE OF SEPTUM DAMAGED / DEFECTIVE AS STATED IN THE PRODUCT INCIDENT REPORT WAS CONCLUSIVE WITH 3 OF THE USED UNITS PROVIDED FOR THIS INCIDENT. CONFIRMED 2 OF THE USED UNITS HAD THE SEPTUM TOP DISK LIFTED FROM THE TOP BODY, OF WHICH ONE HAD A LARGE JAGGED TEAR TO THE COLUMN WALL. CONFIRMED THESE TWO UNITS REVEALED EVIDENCE OF A SUFFICIENT BOND AT TIME OF MANUFACTURE (RESIDUAL SEPTUM MATERIAL AND ADHESIVE DEPOSITS ON THE RIM OF THE TOP BODY). CONFIRMED 1 OF THE USED WAS BROKEN AT THE TOP BODY AND AT THE LUER ALONG WITH THE TOP DISK AND COLUMN (SEPTUM) BEING TORN AWAY FROM THE BOTTOM DISK, WHICH WAS INTACT WITHIN THE BODY (POLYCARBONATE) OF THE Q-SYTE. ROOT CAUSE INDETERMINATE ¿ THE LOCATION WHERE THE TOP DISK WAS LIFTED FROM THE TOP BODY REVEALED EVIDENCE OF ADHESIVE AND SEPTUM RESIDUAL/DEPOSITS AT THE RIM WHICH IS AN INDICATION THAT A BOND WAS PROVIDED DURING THE MANUFACTURING PROCESS. THE DAMAGE OF TORN COLUMN WALL, BROKEN TOP BODY AND LUER ALONG WITH BROKEN/TORN SEPTUM, OBSERVED I THIS INCIDENT REVEALED EVIDENCE OF STRESS / MISUSE. A FAILURE MODE ASSOCIATED WITH THE RETURNED SAMPLES DID NOT INDICATE THAT MANUFACTURING PROCESS INTRODUCED THE DAMAGE OBSERVED. EXTERNAL FORCES MOST LIKELY CONTRIBUTED TO THE DAMAGE OBSERVED. AN INSTRUCTION PAMPHLET IS PROVIDED WITH Q-SYTE PRODUCT. THIS INFORMATION DOCUMENTS THE POTENTIAL FAILURE MODES OF THIS DEVICE IF NOT USED PROPERLY. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE COULD NOT BE IDENTIFIED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.
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.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH SEPTUM DAMAGE. IT WAS STATED ¿THE NURSE FOUND THE EDGE OF THE SEPTUM DAMAGED DURING INFUSION. NO SOLUTION EXPOSURE TO BARE SKIN.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH SEPTUM DAMAGE. IT WAS STATED ¿THE NURSE FOUND THE EDGE OF THE SEPTUM DAMAGED DURING INFUSION. NO SOLUTION EXPOSURE TO BARE SKIN.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WITH THE USE OF THE BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE THERE WAS AN ISSUE WITH SEPTUM DAMAGE. IT WAS STATED ¿THE NURSE FOUND THE EDGE OF THE SEPTUM DAMAGED DURING INFUSION. NO SOLUTION EXPOSURE TO BARE SKIN.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 422960 | 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. | 7004947 | 30382903851004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |