MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-18 for CARDINAL HEALTH CUSTOM HIP PACK SOP34CHBHA manufactured by Cardinal Health.
[60806458]
Custom hip packs from cardinal health appear to be compromised. The surgery staff observed and looked at the packs and noticed puncture wounds that could possibly cause sterility to be impacted. Cardinal health became aware of the situation and came on site to evaluate the incident. They took pictures of the packaging and the location of the punctures. They have sent the pictures and packaging back to their manufacturing plant for evaluation. (b)(6) hospital is awaiting further communication from cardinal as this is a major patient safety issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6121798 |
| MDR Report Key | 6121798 |
| Date Received | 2016-11-18 |
| Date of Report | 2016-11-17 |
| Date of Event | 2016-11-01 |
| Date Facility Aware | 2016-11-01 |
| Report Date | 2016-11-17 |
| Date Added to Maude | 2016-11-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | CARDINAL HEALTH CUSTOM HIP PACK |
| Generic Name | CARDINAL HEALTH CUSTOM HIP PACK |
| Product Code | LRP |
| Date Received | 2016-11-18 |
| Returned To Mfg | 2016-11-17 |
| Model Number | SOP34CHBHA |
| Lot Number | 556108 |
| Device Expiration Date | 2017-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-18 |