MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-06 for GENERAL LAPAROSCOPY PACK 89-8837 manufactured by Deroyal Industries, Inc..
[57294095]
Investigation summary an internal complaint ((b)(4)) was received indicating that a 10cc control top syringe contained in a general laparoscopy pack (finished good (b)(4), lot 40991259) broke when injecting local into an incision site. The defective sample could not be returned because the reporting customer was unable to decontaminate the product. Therefore, photos were provided of the actual defective product, which confirm the reported issue. The raw material syringe contained within the convenience kit is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request was sent to (b)(4). The response is due october 20, 2016. The work order for the finished good was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The investigation is incomplete at this time. When new and critical information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[57294096]
When injecting local into the incision site with the 10cc control top syringe, the top of the syringe broke off. It caused additional or time as the team needed to open an additional syringe to administer more local anesthetic into the incision sites. A rough estimate would be about three minutes to open another syringe and draw up local. This occurred during a laparoscopic cholecystectomy. No injury was reported and no other intervention was needed except to open another syringe to administer additional local anesthetic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2016-00028 |
| MDR Report Key | 6004094 |
| Date Received | 2016-10-06 |
| Date of Report | 2016-10-06 |
| Date of Event | 2016-09-06 |
| Date Mfgr Received | 2016-09-06 |
| Date Added to Maude | 2016-10-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELIZABETH REED |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621256 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1501 EAST CENTRAL AVENUE |
| Manufacturer City | LAFOLLETTE TN 37766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GENERAL LAPAROSCOPY PACK |
| Generic Name | LAPAROSCOPY KIT |
| Product Code | FDE |
| Date Received | 2016-10-06 |
| Model Number | 89-8837 |
| Lot Number | 40991259 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-06 |