MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-04-11 for PENCIL,45 ABC,FT/S,DISP/10 130345 manufactured by Consolidated Medical Equipment.
[105644425]
The reported unused devices were returned for evaluation in their original unopened package. Label verification and visual inspection were performed. Visual inspection of the devices found a hole in the packaging of the device which caused a breach in sterility. The location of the hole was near the seal area on the inner side. The location of the hole was not near any feature of the devices that are likely to cause a hole; therefore, it is likely that this hole was caused from the outside of the packaging inward. The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product. The product released for distribution were found to have met all specifications prior to shipment. This is the only complaint for this lot number and failure mode within the (b)(4). A (b)(4) review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) devices, for this device family and failure mode. During this same time frame (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following: these device should be inspected before use. Visually examine the devices for obvious physical damage and do not use if you find: cracked, broken or otherwise distorted plastic parts, broken or significantly bent handle, shaft or connector contacts. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[105644426]
The distributor in (b)(4) reported a "tear" on the sterile pouch of this 130345 pencil. There was no patient involvement as this defect was discovered during incoming inspection. This report is raised on the basis of a malfunction due to a sterility breach found during the device evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2018-00080 |
| MDR Report Key | 7423351 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-11 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2016-11-29 |
| Date Added to Maude | 2018-04-11 |
| 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 | MR. JOHN BERGA |
| Manufacturer Street | 11311 CONCEPT BLVD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995358 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, 31136 |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCIL,45 ABC,FT/S,DISP/10 |
| Generic Name | ABC HANDPIECES-OPEN |
| Product Code | HAM |
| Date Received | 2018-04-11 |
| Returned To Mfg | 2018-02-26 |
| Catalog Number | 130345 |
| Lot Number | 201611294 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA, 31136 MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-11 |