MAUDE Adverse Event Report: HALYARD HEALTH KC100 WRAP 30X30 STERILIZATION WRAP KIMGUARD

Model Number 10730

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(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).

Event Description

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.

Manufacturer Narrative

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).

• Brand Name: KC100 WRAP 30X30
• Type of Device: STERILIZATION WRAP KIMGUARD
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): HALYARD NORTH CAROLINA, INC.; 389 clyde fitzgerald road; linwood NC 27299
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5778806
• MDR Text Key: 49071080
• Report Number: 1054380-2016-00014
• Device Sequence Number: 1
• Product Code: FRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/06/2020
• Device Model Number: 10730
• Device Catalogue Number: 991010730
• Device Lot Number: LN5157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2015
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage