MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER; INTRAVASCULAR CATHETER

Model Number	381323
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insyte-w¿ peripheral venous catheter the experienced needle through catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from dutch to english: recently found multiple needles on l1 and m2 where iv needle is defective.Plastic catheter is on hook.Basically this a problem that does happen more often when you've just made the wrong angle and are against the vessel wall, but could of course be that in these cases plastic was also affected beforehand.Have only seen it with blue needles.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issues of catheter tip integrity and catheter kink / bent was confirmed upon inspection of the photo.However, bd cannot confirm the causes of the failures to our manufacturing process since no sample was returned for evaluation.Device history record of packaged needle (pn) batch 2054679 catalogue number 381323 and its assembled needle (an) batches 2055139 and 1359563, part number 8083541 were reviewed.
Event or Problem Description
It was reported while using bd insyte-w¿ peripheral venous catheter the experienced needle through catheter.There was no report of patient impact.The following information was provided by the initial reporter, translated from dutch to english: recently found multiple needles on l1 and m2 where iv needle is defective.Plastic catheter is on hook.Basically this a problem that does happen more often when you've just made the wrong angle and are against the vessel wall, but could of course be that in these cases plastic was also affected beforehand.Have only seen it with blue needles.

• Brand Name: BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15993585
• Report Number: 8041187-2022-00740
• Device Sequence Number: 14870874
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: (01)30382903813231
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2022

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
• Operator of Device: Other
• Device Model Number: 381323
• Device Catalogue Number: 381323
• Device Lot Number: 2054679
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown