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

Model Number	381323
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 the bd insyte¿ iv catheter needle pierced through the catheter after entering the vein.The following information was provided by the initial reporter, translated from french: "once in the vein the bevel pierces the cannula.This has happened several times.The vet has been using our catheter for about ten years without any problems.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 30-jun-2022.H6: investigation summary: two photos and one actual sample without packaging were received by our quality team for evaluation.From the photos, the needle pierced through the catheter tip area was observed.The sample was subjected to visual inspection, a ¿v-cut¿ was observed near to the catheter tip.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.From the returned sample, a ¿v-cut¿ was observed on the catheter that matches the shape of the bevel, which could be caused by the needle pierced through the catheter.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the inline tip spear vision inspection system.Needle pierced through catheter could also happen during product application when the product was manipulated or during the needle cover removal if not done carefully.As the sample was returned without packaging, the actual root cause could not be established.
Event or Problem Description
It was reported that the bd insyte¿ iv catheter needle pierced through the catheter after entering the vein.The following information was provided by the initial reporter, translated from french: "once in the vein the bevel pierces the cannula.This has happened several times.The vet has been using our catheter for about ten years without any problems.".

• Brand Name: BD INSYTE¿ IV 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: 14743607
• Report Number: 8041187-2022-00317
• Device Sequence Number: 5288402
• Product Code: FOZ
• UDI-Device Identifier: 30382903813231
• UDI-Public: 30382903813231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/25/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 381323
• Device Catalogue Number: 381323
• Device Lot Number: 1230787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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