MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ PERIPHERAL IV CANNULA WITH BD VIALON¿ BIOMATERIAL; INTRAVASCULAR CATHETER

Catalog Number	381223
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd insyte¿ peripheral iv cannula with bd vialon¿ biomaterial needle pierced through and became stuck in the cap before use.The following information was provided by the initial reporter: "out of box failure - tech opened new catheter and found needle stuck in plastic cap".
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?yes.D10: returned to manufacturer on: 21-jul-2023 h6: investigation summary a device history record review was completed for provided material number 381223 and lot number 2115926.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) picture sample and the affected physical sample were returned for evaluation by our quality team.Through inspection of the sample, the needle was observed pulled out of the hub.There were no traces of adhesive found inside of the needle hub or on the end of the needle to indicate that the adhesive had been dispensed into the needle hub during production.The defective product most likely resulted from a failure in the station that applies the adhesive.
Event or Problem Description
It was reported that the bd insyte¿ peripheral iv cannula with bd vialon¿ biomaterial needle pierced through and became stuck in the cap before use.The following information was provided by the initial reporter: "out of box failure - tech opened new catheter and found needle stuck in plastic cap".

• Brand Name: BD INSYTE¿ PERIPHERAL IV CANNULA WITH BD VIALON¿ BIOMATERIAL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17007836
• Report Number: 8041187-2023-00231
• Device Sequence Number: 15245839
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: 00382903812233
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/26/2023

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: Health Professional
• Device Catalogue Number: 381223
• Device Lot Number: 2115926
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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