MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-26 for UNK V. MUELLER manufactured by Carefusion.
[18361610]
Damaged product medwatch (b)(4). Additional information received from the customer (b)(4) 2014. The customer stated that our tebbetts retractors were attached to the light source when the light source frayed and fell into the patient's open breast. He did not believe there was any patient harm. He stated he had no further information at this time. He stated that the instruments would not be sent for evaluation but did offer to allow us to come to the facility to evaluated during a customer visit.
Patient Sequence No: 1, Text Type: D, B5
[18403894]
(b)(4). Should additional information be received, a follow-up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[34902560]
(b)(4) further information was obtained by the sales rep during his visit to the facility on (b)(6) 2014. The sales rep reported that there were four (4) tebbetts retractors used in the case, which is two (2) more then originally reported by the customer. The lot numbers and product numbers were unknown. The hospital could not identify which of the four tebbetts retractor was used in the case. No photos were taken of the tebbetts retractors. The bio med manager tested all four of the retractors and did not find any issues. The sales rep was able to take pictures of the light cable (product code (b)(4),lot number 833502) listed in case (b)(4) whos investigation concluded created the failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2014-00036 |
| MDR Report Key | 3701317 |
| Report Source | 05 |
| Date Received | 2014-03-26 |
| Date of Report | 2014-03-26 |
| Date of Event | 2014-03-06 |
| Date Mfgr Received | 2014-03-06 |
| Date Added to Maude | 2014-05-22 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200, INC. SNOWDEN PENCER PRODUCTS |
| Manufacturer Street | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER 30084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK V. MUELLER |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2014-03-26 |
| Model Number | UNK V. MUELLER |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-26 |