MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for GLOVE SURGICAL TRIFEX 2D7255I manufactured by Cardinal Health (thailand) 222 Limited.
[146058325]
At the time of this investigation no sample or lot number was provided. Without the lot number and sample, we were not able to review the device history record (dhr) and we were not able to evaluate the issue sample. We were unable to determine the root cause for the reported event. If a sample is provided at a later date a follow-up will be provided. At this time no corrective action will be taken. We will continue monitoring our customer complaints data base for this and any other issues reported of the same nature.
Patient Sequence No: 1, Text Type: N, H10
[146058326]
Based on information received from the customer, a chest tube was inserted on (b)(6) 2019 and then replaced on (b)(6) 2019 when the patient later had surgery a fingertip of the glove was reportedly found in the chest cavity. The physician was unaware it had pulled off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2019-00318 |
| MDR Report Key | 8636590 |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-23 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-23 |
| 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 | 3651 BIRCHWOOD DRIVE |
| 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 TRIFEX |
| Generic Name | SURGEON'S GLOVES |
| Product Code | KGO |
| Date Received | 2019-05-23 |
| Model Number | 2D7255I |
| Catalog Number | 2D7255I |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-05-23 |