MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN BACTISEAL EVD CATHETER; BACTISEAL EVD CATHETERS

Catalog Number 821745

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the paper on the internal part of the blister and the blister are glued due to excessive quantity of glue.No consequences for the patient; however, the event led to approximately 30 minutes of surgical delay.

Manufacturer Narrative

Investigation update: failure analysis - the products were opened and investigated under microscope at appropriate magnification when necessary.It was noted that the paper lids were curled (undulations).It was noted that the catheters left an orange coloration on the paper lids and also catheters had glue traces.The 2 red caps were found stuck to the paper lids, and had some glue traces on them.The complaint was confirmed.The issue is linked to the design of the lid that is glued on its totality.A non-conformance (nc) had been initiated.The nc asked for further testing to verify antibiotics efficiency.The results of zoi tests confirmed that there was no impact on antibiotics efficiency nor on patient safety.The issue is cosmetic only.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Other mfg report number - 3013886523-2021-00148.Sample was returned for evaluation: dhr - lot 5136193 conformed to the specifications when released to stock.Failure analysis - 2 x "bactiseal evd catheter set" were returned for investigation.The products were opened and investigated under microscope at appropriate magnification when necessary.It was noted that the paper lids were curled (ondulations).It was also noted that one of the catheters did an orange coloration on the paper lid and this catheter had glue traces on it.The 2 red caps were found with some glue traces.Root cause: the issues reported by the customer (¿paper of the blister is orange; excessive quantity of glue¿) were found, but no component was found glued against the paper of the blister.Nevertheless, some glue traces were found on catheters and on red caps.The root cause for ¿catheter antibiotics stain packaging material¿ was due to ¿blister material selection / catheter and packaging interaction¿.The root cause for ¿components are glued against the paper of the blister¿ can be due to ¿improper packaging materials, inadequate seal strengths or packaging configuration, not compatible with sterilization technique¿.Nevertheless, since the customer decided not to use the products with ¿excessive quantity of glue¿ there was not patient¿s impact and complaint will be closed as ¿user dissatisfaction¿.As specified in the ifu, at the section ¿precautions¿: ¿inspect the sterile package carefully.Do not use if: the package or seal appears damaged; contents appear damaged¿.

• Brand Name: CODMAN BACTISEAL EVD CATHETER
• Type of Device: BACTISEAL EVD CATHETERS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11599713
• MDR Text Key: 243281479
• Report Number: 3013886523-2021-00149
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K102589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2021

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: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 821745
• Device Lot Number: 5123852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 10/13/2021; 12/02/2021
• Supplement Dates FDA Received: 10/28/2021; 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1