MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-11-01 for NOZZLE,STRAIGHT,ABC,DISP/20 130343 manufactured by Consolidated Medical Equipment.
[91333652]
The reported 70 devices were returned to conmed in their original unopened packages for evaluation. All 70 devices were visually inspected. Fifty-seven (57) devices were observed to have a channel in the center of the chevron seal. Thirteen (13) samples were observed to have a seal area less than 1/4" at the center of the chevron seal. Per established aql level, 13 of these 70 devices were selected at random and a packaging engineer performed further testing. It was determined that 8 devices had a breach in sterility and 5 had a seal area less than? " on the chevron seal that did not compromise sterility. Movement of the device within the pouch is restricted due to the rubber components that interact with pet side of the pouch; therefore, the packaging system was compromised. The manufacturing documents were reviewed and the devices within this lot were verified to have been produced according to current and approved procedures and material specifications. Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture. No prior incidences have been reported against this lot of 800 units. A two-year historical complaint review revealed no similar events have been reported for this device. This reported packaging issues were obvious to the distributor, prompting the return of the devices for evaluation. There was no patient involvement. As with all medical devices, examination of the product occurs multiple times prior to use. Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact. The instructions for use (ifu) provides the following warning. If packaging has been opened/damaged or altered, do not use the product and contact the manufacturer immediately. This incident has been escalated for further investigation and will continue to be monitored through the complaint system.
Patient Sequence No: 1, Text Type: N, H10
[91333653]
A conmed representative reported the distributor in (b)(4) rejected 70 130343 abc nozzles due to sealing issues. In this instance, there was no patient involvement as the packaging anomaly was discovered during inspection prior to distribution to an end-user. The report is raised on the basis of a device malfunction with potential for injury with recurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2017-00233 |
| MDR Report Key | 6992912 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-11-01 |
| Date of Report | 2017-11-01 |
| Date Mfgr Received | 2017-10-13 |
| Device Manufacturer Date | 2017-03-29 |
| Date Added to Maude | 2017-11-01 |
| 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 | LINDSEY SHEPPARD |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOZZLE,STRAIGHT,ABC,DISP/20 |
| Generic Name | ABC NOZZLE |
| Product Code | HAM |
| Date Received | 2017-11-01 |
| Returned To Mfg | 2017-10-23 |
| Catalog Number | 130343 |
| Lot Number | 201703294 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, CHIHUAHUA 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-01 |