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

Catalog Number	381334
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(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 bd insyte¿ iv catheter leaked.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: a review of the device history record revealed no irregularities during the manufacture of the reported lot.1 used actual sample was returned without packaging and cannula assembly.Returned sample.The actual sample was subjected to visual inspection.No abnormalities were observed on the returned sample.No abnormalities observed.The returned sample was subjected to leak test.The sample had passed the leak test.The root cause of the nonconformance could not be confirmed as the returned sample showed no abnormalities and had passed the leak test.However, review of the past 12 months qn was performed.Qn# (b)(4) was raised in jan 2018 due to dented adapter inner luer (affected batch: mat# 382412, batch#8 004281).The root cause was due to the misalignment at adapter pick and place station, the holder screw was broken causing dented inner luer during pick up the parts from pallet.Corrective action has been implemented, the holder screw and alignment condition will be checked every start of the shift and a monthly pm has been established to change the holder screw.Catheter adapter leakage test was performed during outgoing inspection, all the batches were released upon passed the outgoing test.The returned sample showed no abnormalities and had passed the leak test.
Event or Problem Description
It was reported that bd insyte¿ iv catheter leaked.No serious injury or medical intervention was reported.

• Brand Name: BD INSYTE¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8066462
• Report Number: 8041187-2018-00412
• Device Sequence Number: 2279259
• Product Code: FOZ
• UDI-Device Identifier: 30382903813347
• UDI-Public: 30382903813347
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 381334
• Device Lot Number: 8110386
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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