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

Catalog Number	381311
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
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 catheter split while trying to insert a bd insyte-n¿ peripheral venous catheter, requiring additional iv attempts.It was reported that the patient was septic and this delayed their ¿urgent iv antibiotics¿.No additional medical interventions were reported.
Event or Problem Description
It was reported that the catheter split while trying to insert a bd insyte-n peripheral venous catheter, requiring additional iv attempts.It was reported that the patient was septic and this delayed their ¿urgent iv antibiotics¿.No additional medical interventions were reported.
Additional Manufacturer Narrative
Three actual samples without packaging were returned for investigation.The actual samples were subjected to visual inspection.V-cut was observed on all returned samples.Dhr- no quality notification was raised for similar nonconformance during the production of this batch.The v-cut could have been caused by the cannula pierced through catheter.The cannula pierced through catheter occurred during assembly of catheter and cannula or during product application when the product was manipulated.However, there is an automated vision inspection machine, which can detect and reject product with cannula pierced through catheter in the assembly process.Hence, the root cause of the nonconformance could not be determined.

• Brand Name: BD INSYTE-N¿ PERIPHERAL VENOUS CATHETER
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7953632
• Report Number: 8041187-2018-00367
• Device Sequence Number: 1525500
• Product Code: FOZ
• UDI-Device Identifier: 00382903813117
• UDI-Public: 00382903813117
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 05/31/2023
• Device Catalogue Number: 381311
• Device Lot Number: 8136218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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