FDA Adverse Event
Malfunction
Summary report: N
DAFILON BLUE 4/0 (1.5) 45CM DSMP16 (M)
MDR report key: 3960945
·
Received May 23, 2014
Report
- Report Number
- 2916714-2014-00372
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Date of Event
- March 12, 2014
- Report Date
- May 23, 2014
- Manufacturer
- B. BRAUN SURGICAL S.A.
- Product Code
- GAR
- PMA / PMN Number
- K990090
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
US REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: EVALUATION IS ON-GOING AT MANUFACTURING SITE.
Description of Event or Problem · 1
COUNTRY OF COMPLAINT: (B)(6). DURING THE TEST PHASE OF OUR NEEDLES, IT IS CLAIMED THAT THE NEEDLE QUALITY IS DEFICIENT. NEEDLE SHARPNESS IS NOT EFFICIENT, AND THE CUT OF ETHICON NEEDLE IS LONGER. ALSO, THE NEEDLE END CRACKED DOWN AT THE END OF THE ARMORING, AS A RESULT, YOU CAN NOT USE THE FULL LENGTH. SOMETIMES YOU ARE FORCED TO GRAB THE NEEDLE AT THE END TO PENETRATE THE TISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309219 | DAFILON BLUE 4/0 (1.5) 45CM DSMP16 (M) | NYLON SUTURE | GAR | B. BRAUN SURGICAL S.A. | C0936162 | 613394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |