MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-03-04 for CODMAN DISPOSABLE SCALP CLIP APPLIER 20-1038 manufactured by Codman & Shurtleff, Inc..
[16600017]
The affiliate reported: it was reported that the foreign matter (reported as yellow liquid) had been found on the product inside the sterilized package. Another product was used to complete the case. There were no surgical delay greater than 30 min and no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[16845864]
Upon completion of the investigation, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[34911551]
Per the creation of (b)(4), the contact reported finding foreign matter (reported as yellow liquid) on the product inside the sterilized package. A 2nd complaint with the same description was created per (b)(4). Seven products were returned with four of them being unopened (for (b)(4)). The product code is 20-1038 (disposable scalp clip applier). The lot code provided was 363631. Upon completion of the investigation, the operators were retrained to mps-pc509. Internal operations were reviewed for the assembling of disposable scalp clip appliers. Per mps-pc509 rev u, the use of an oil lubricant is permitted. For lot code 363631, a yellow spot was seen on the tyvek lid and on the tip of the clip applier. In disassembling one of the returned and opened components, an oil track (or drip line) was observed. It was concluded the fluid is the oil lubricant. A procedure exists for the lubrication of the clip sleeve (refer to mps-pc509 rev u). Manual operation includes placing three drops of oil in the indicated area. The root cause can most likely be attributed to human error as the lubrication process is a manual operation. Upon disassembling one of the returned products, a trail of oil was found along the entire length of the device, originating from the clip sleeve. An excessive amount of oil was added to the product and ultimately contributed to the runoff of oil. The production records for this lot were reviewed and no non-conformances were found. Trends will be monitored for this and similar complaints. At the present time, this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2014-11285 |
| MDR Report Key | 3658252 |
| Report Source | 01,07 |
| Date Received | 2014-03-04 |
| Date of Event | 2014-02-24 |
| Date Mfgr Received | 2014-04-04 |
| Date Added to Maude | 2014-05-13 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN DISPOSABLE SCALP CLIP APPLIER |
| Generic Name | APPLIER, SURGICAL, CLIP |
| Product Code | HBO |
| Date Received | 2014-03-04 |
| Catalog Number | 20-1038 |
| Lot Number | 363631 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-04 |