MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 INFECTION CONTROL URINARY DRAINAGE BAG; DRAIN BAG

Catalog Number 154004A

Device Problem Device Packaging Compromised (2916)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that upon receiving the product the package was open.

Manufacturer Narrative

Received 1 opened urinary drainage bag in the original unit packaging.Visual inspection noted that the package was opened upon return.Further inspection noted that the package appeared to have been sealed properly due to the tyvek residue still being adhered to the clear plastic.There were no damages, tears or holes noted on the returned sample.There were no manufacturing deficiencies observed on the returned sample that would have contributed to the reported issue.The visual inspection concluded that the package had been opened after being sealed due to the tyvek residue still being adhered to the clear plastic of the returned device packaging.A peel strength test was performed and it was found that the packaging was within specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "directions for use: - sterile unless package has been opened or damaged.- directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use." the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: INFECTION CONTROL URINARY DRAINAGE BAG
• Type of Device: DRAIN BAG
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5186038
• MDR Text Key: 30104143
• Report Number: 1018233-2015-00415
• Device Sequence Number: 1
• Product Code: KNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2018
• Device Catalogue Number: 154004A
• Device Lot Number: NGZF1606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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