MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE ACMF CARDIO PACK BLUE 2; SURGICAL PACKS

Model Number 77762

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Kimberly-clark received a report from (b)(6) stating, ¿the plastic bag in which the set is packaged is not welded properly.The customer could not use the 4 sets, since they are sterile.The seal is only a part open, the weld is risen again.In the 13 cases (13 cases x 2 packs) inspected we found 3 packs with a broken seal.It seems that the packs burst on the edge due to the pressure.For some of the other packs the seal which is at 1 cm wide was starting to open from the interior, leaving just a few millimeters of unbroken seal at the exterior side." (b)(4).

Manufacturer Narrative

We are unable to review the device history record as no lot number was provided for the device involved in this reported event.The device was not returned to kimberly-clark for evaluation, therefore we are unable to determine a root cause for the reported event.Information from this incident will be included in our product complaint and mdr trend reporting systems.Ongoing analysis of trend information is used to identify the need for additional investigations.

• Brand Name: ACMF CARDIO PACK BLUE 2
• Type of Device: SURGICAL PACKS
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge road; roswell GA 30076
• Manufacturer (Section G): AVENT S DE RL DE CV/NOGALES 3; av. hidalgo #6; esquina blvd luis donaldo colosio, col. educativa; nogales, sonora 8409 3; MX 84093
• Manufacturer Contact: ra/qa ae coordinator ; 1400 holcomb bridge road; roswell, GA 30076
• MDR Report Key: 3929628
• MDR Text Key: 4605232
• Report Number: 1033422-2014-00018
• Device Sequence Number: 1
• Product Code: FYC
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 77762
• Device Catalogue Number: 991077762
• Device Lot Number: AC322103B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1