FDA Adverse Event
Malfunction
Summary report: N
MONOSYN VIOLET 1 (4) 90CM HR48 (M)
MDR report key: 3850394
·
Received March 18, 2014
Report
- Report Number
- 2916714-2014-00161
- Event Type
- Malfunction
- Date Received
- March 18, 2014
- Report Date
- March 18, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- GAM
- PMA / PMN Number
- K011375
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON (B)(6) 2014. MFG SITE EVAL: SAMPLES RECEIVED: 44 UNOPENED POUCHES. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. ALL PACKS RECEIVED ARE TIGHT. NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED WAS TESTED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. REVIEW THE BATCH MFG RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/ PREVENTIVE ACTIONS: NOT APPLICABLE.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). DETACHMENT OF NEEDLE FROM THREAD AFTER THE OPENING OF THE BLISTER PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159838 | MONOSYN VIOLET 1 (4) 90CM HR48 (M) | ABSORBABLE SUTURE | GAM | B. BRAUN SURGICAL S.A. | C0022078 | 113252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |