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

Catalog Number	381323
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 1 bd insyte-w¿ peripheral venous catheter had needle through the catheter issues.The following information was provided by the initial reporter translated from french to english : the user reported that during a catheterization of a dog with a catheter insyte blue thread 0.9x25mm, when starting to remove the mandrel without taking it out completely there was no blood return so it was put back in and realized that it was blocked and a potato had formed at the vein.On removing the catheter it was notice that the mandrel is blunt and had pierced the catheter.
Event or Problem Description
It was reported that 1 bd insyte-w¿ peripheral venous catheter had needle through the catheter issues.The following information was provided by the initial reporter translated from french to english : the user reported that during a catheterization of a dog with a catheter insyte blue thread 0.9x25mm, when starting to remove the mandrel without taking it out completely there was no blood return so it was put back in and realized that it was blocked and a potato had formed at the vein.On removing the catheter it was notice that the mandrel is blunt and had pierced the catheter.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 05-jul-2022.H6: investigation summary: one actual sample with open packaging were received by our quality team for evaluation.The sample was subjected to visual inspection to check for needle pierced through the catheter.From the returned sample, the needle was observed to be pierced through the catheter near the tip area.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.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 during the needle cover removal if not done carefully.As the actual sample was returned in open packaging, the root cause could not be established.

• 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: 14982770
• Report Number: 8041187-2022-00356
• Device Sequence Number: 5099016
• Product Code: FOZ
• UDI-Device Identifier: 00382903813230
• UDI-Public: 00382903813230
• 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): 07/28/2022

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 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: 06/13/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/24/2022
• 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