FDA Adverse Event
Malfunction
Summary report: N
QUILL KNOTLESS TISSUE CLOSURE DEVICE
MDR report key: 4462806
·
Received January 28, 2015
Report
- Report Number
- 3008845715-2015-00005
- Event Type
- Malfunction
- Date Received
- January 28, 2015
- Date of Event
- January 16, 2015
- Report Date
- January 26, 2015
- Manufacturer
- SURGICAL SPECIALTIES PUERTO RICO INC.
- Product Code
- NEW
- PMA / PMN Number
- K072028
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL BE RETURNED. METHOD: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL BE RETURNED. NO INVENTORY AVAILABLE FOR THE LOT REPORTED; NOR COMPONENT LOT NUMBER. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES (B)(6) INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED "TWO NEEDLES HAD BROKEN BETWEEN SEWING SUBCUTANEOUS TISSUE." (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65499 | QUILL KNOTLESS TISSUE CLOSURE DEVICE | BARBED MATERIAL/NEEDLES | NEW | SURGICAL SPECIALTIES PUERTO RICO INC. | YA-2024Q | MQ51010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | NONE MADE AVAILABLE |