MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE ¿ IV CATHETER VIALON-E WINGED INTRAVASCULAR CATHETER

Catalog Number 388434

Device Problem Device Packaging Compromised (2916)

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

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation results: 4 photos were returned for investigation. Opened seal was observed in the returned photos. 3 actual samples in opened packaging were returned for investigation. The actual samples were subjected to visual inspection. Our quality engineer inspected the returned units and confirmed the reported observation but could not identify any manufacturing related defects. Opened seal was observed on all returned samples for batch 3322458, batch 4297106, and batch 5354382. Device history record was reviewed for all three batches and no quality notification was raised for similar nonconformance during the production of any incident batch. Conclusion: there is an indication of adhesive transferred from the top web to the bottom web on the opened seal areas, which was present on all returned samples and thus, showed 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.

Manufacturer Narrative

There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 3322458, medical device expiration date: 2018-11-30, device manufacture date: 2013-12-21. Medical device lot #: 5354382, medical device expiration date:2020-12-31, device manufacture date: 2016-01-18. Medical device lot #: 4297106, medical device expiration date: 2019-10-31, device manufacture date: 2014-12-06. 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 vialon-e was found with a breach in package integrity. There was no report of injury or medical intervention reported.

• Brand Name: BD INSYTE ¿ IV CATHETER VIALON-E WINGED
• Type of Device: INTRAVASCULAR 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: 7164340
• MDR Text Key: 251788799
• Report Number: 8041187-2017-00280
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388434
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/11/2017
• 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 Treatment Data

Date Received: 01/04/2018 Patient Sequence Number: 1