MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-27 for ANGIOGRAPHY PACK DYNJ38846 manufactured by Medline Industries, Inc..
[65942530]
Patient Sequence No: 1, Text Type: N, H10
[65942531]
Disposable scalpel from angiopack was checked by the scrub personnel immediately prior to procedure for appropriate function without noted problem. During the case, the physician used the scalpel and attempted to retract the blade which fell apart into 2 pieces. No patient or staff harm noted. Manufacturer response for angiography pack, angiography pack (per site reporter): reported to medline customer service representative. Email confirmation to be sent with instructions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6282500 |
| MDR Report Key | 6282500 |
| Date Received | 2017-01-27 |
| Date of Report | 2017-01-17 |
| Date of Event | 2016-10-05 |
| Report Date | 2016-11-17 |
| Date Reported to FDA | 2016-11-17 |
| Date Reported to Mfgr | 2016-11-17 |
| Date Added to Maude | 2017-01-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIOGRAPHY PACK |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2017-01-27 |
| Catalog Number | DYNJ38846 |
| Lot Number | 16PB3016 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1170 S. NORTHPOINT BLVD. WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-27 |