MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-02 for GLOVE SURGICAL PROTEXIS PI MICRO UNKNOWN manufactured by Cardinal Health (thailand) 222 Limited.
[144139493]
The actual catalog number (and lot number) of the protexis pi micro glove that was worn are not known. No other specifics about the event or the physician have been provided. The manufacturing facility has determined that the potential root cause is the use of an alternate new source for the polyisoprene which is used in the manufacture of the gloves. The new source of polyisoprene had less tear resistance than the previous source for the same thickness control. As of october 2018 cardinal health has reverted back to the original supplier and the first lot released in europe was ts18100005. The customer is returning "representative samples". However, the manufacturing facility does not need samples to be returned for evaluation as they identified the problem. If the "representative samples" are received and their evaluation reveals a different root cause, then a follow up report would be filed. We will continue to monitor complaints for such issues.
Patient Sequence No: 1, Text Type: N, H10
[144139494]
During a cardiac procedure ((b)(6)), the protexis pi micro gloves tore, and the surgeon had blood on his hands. The patient was (b)(6). No other information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00314 |
| MDR Report Key | 8573977 |
| Date Received | 2019-05-02 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-04-08 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-05-02 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Street | 7/111 MOO 4 HIGHWAY #331, MABY |
| Manufacturer City | RAYONG 21140 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 21140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLOVE SURGICAL PROTEXIS PI MICRO |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-05-02 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH (THAILAND) 222 LIMITED |
| Manufacturer Address | 7/111 MOO 4 HIGHWAY #331, MABY RAYONG 21140 TH 21140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-02 |