MAUDE Adverse Event Report: BAXTER HEALTHCARE - CASTLEBAR ACCUSOL; STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE

Catalog Number RPE9249

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

During evaluation of a returned accusol solution bag for clearflex was reported to have a tear on the apex of the long peel seal with the print side up.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).The device was returned for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A visual inspection was performed and a tear approximately 4mm in length on the apex of the long peel seal, print side up was found.However, the cause was not determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCUSOL
• Type of Device: STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): BAXTER HEALTHCARE - CASTLEBAR; moneen road; castelbar ; EI
• Manufacturer (Section G): BAXTER HEALTHCARE - CASTLEBAR; moneen road; castelbar ; EI
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4392388
• MDR Text Key: 5362504
• Report Number: 1416980-2015-00682
• Device Sequence Number: 1
• Product Code: KPI
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: RPE9249
• Device Lot Number: 13I05G71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 01/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1