MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER; INTRAVENOUS CATHETER

Catalog Number 388412

Device Problems Component Missing (2306); Device Packaging Compromised (2916)

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

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 5324029, medical device expiration date: 2020-11-30, device manufacture date: 2015-12-21.Medical device lot #: 3322452, medical device expiration date: 2018-11-30, device manufacture date: 2014-01-06.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that before use, a bd insyte¿ iv catheter was found with a breach of package integrity as well as missing supplies.No report of injury or medical intervention reported.

Manufacturer Narrative

Investigation results: 4 photos were returned for investigation.2 actual samples in opened packaging from batch 3322452, and batch 5324029 were returned for investigation.Our quality engineer inspected the returned units and photos, and confirmed the reported complaint but could not identify any manufacturing related defects.The actual sample from batch 5324029 was found to be empty.A device history record review was conducted for both batches and no quality notification was raised for similar nonconformance during the production of the batches.Conclusions: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal areas, which was present on both returned samples showing that the sealing process was completed in manufacturing facility.Therefore, no assignable root cause can be established.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

• Brand Name: BD INSYTE¿ IV CATHETER
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7164433
• MDR Text Key: 96628843
• Report Number: 8041187-2017-00283
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K942045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 388412
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other