MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2016-07-08 for KC100 WRAP 30X30 10730 991010730 manufactured by Halyard Health.
[49071080]
(b)(4). Five unused lot samples were returned for evaluation. Visual examination revealed that there were slits found in all, around the center of the wraps. All the slits exhibited a very fine edge with no jaggedness. Additional investigation into root cause is in progress. A follow up report will be filed. The device history record for ln5157 was reviewed and the product was produced according to product specifications. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[49071081]
It was reported that the customer uses the wraps to sterilize bowls. While unwrapping the bowls in the o. R. , the nurse noticed long cuts in the wrap. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[51265784]
No root cause for the reported event could be identified. Tear/cut/holes made in converting or base fabric manufacturing are not consistent with the shape/size identified in the evaluation. As a result, a manufacturing related cause has been ruled out. The cuts found on the fabric are consistent with the kind made by a knife. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1054380-2016-00014 |
| MDR Report Key | 5778806 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2016-07-08 |
| Date of Report | 2016-07-19 |
| Date Mfgr Received | 2016-07-19 |
| Device Manufacturer Date | 2015-06-07 |
| Date Added to Maude | 2016-07-08 |
| 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 | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | HALYARD NORTH CAROLINA, INC. |
| Manufacturer Street | 389 CLYDE FITZGERALD ROAD |
| Manufacturer City | LINWOOD NC 27299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KC100 WRAP 30X30 |
| Generic Name | STERILIZATION WRAP KIMGUARD |
| Product Code | FRG |
| Date Received | 2016-07-08 |
| Returned To Mfg | 2016-06-27 |
| Model Number | 10730 |
| Catalog Number | 991010730 |
| Lot Number | LN5157 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-08 |