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

Catalog Number	381267
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Three potential lot numbers were provided for this incident.The information for each lot number is as follows: medical device lot #: 6025358, medical device expiration date: 01/31/2021, device manufacture date: 02/27/2016.Medical device lot #: 6077264, medical device expiration date: 03/31/2021, device manufacture date: 05/10/2016.Medical device lot #: 5289439, medical device expiration date: 10/31/2020, device manufacture date: 11/24/2015.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that some bd insyte¿ iv catheter non-winged secondary packages were found open or with poor seal integrity prior to use.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Results: our quality engineer inspected the returned units and confirmed the reported observation.The source of the reported issue could not be determined.Dhr for all three lot numbers showed no issues.No manufacturing related defects were identified during the evaluation of the samples.Ten actual samples in opened packaging were returned for investigation.The actual samples were subjected to visual inspection.Opened seal was observed on all the returned samples.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.

• Brand Name: BD INSYTE¿ IV CATHETER NON-WINGED
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7124532
• Report Number: 8041187-2017-00252
• Device Sequence Number: 11118711
• Product Code: FOZ
• UDI-Device Identifier: 00382903812677
• UDI-Public: 00382903812677
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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
• Operator of Device: Other
• Device Catalogue Number: 381267
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other