MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD BARD URINARY 2 LITE DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

Catalog Number 154006

Device Problems Hole In Material (1293); Device Packaging Compromised (2916)

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

Event Date 12/12/2014

Event Type  malfunction  

Event Description

It was reported that bard medical division (bmd) was notified by the (b)(4) manufacturing site that during bard 100% latex-free urinary drainage bag inspection, they found holes/tears in the packaging tyvek that leaked when challenged with blue dye water.The subject product is sold sterile.On (b)(6) 2014, it was confirmed that it impacted this lot released into distribution.

Manufacturer Narrative

This medwatch is not associated with a customer complaint or reported adverse event; however, it is being filed in accordance with 21 cfr part 803.53.Investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

• Brand Name: BARD URINARY 2 LITE DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sononara ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km 7 carretera internacional; nogales, sonora ; MX
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4454773
• MDR Text Key: 5426422
• Report Number: 1018233-2014-00353
• Device Sequence Number: 1
• Product Code: KNX
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 154006
• Device Lot Number: NGYJ1671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2014
• 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