MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515008

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported when using the bd phaseal¿ injector luer lock n35j the device was damaged/deformed product - device is operable.The following information was provided by the initial reporter.The customer stated: "a defect on the connection interface of the injector was found before preparation.The claws at the connection are deformed.".

Event Description

It was reported when using the bd phaseal¿ injector luer lock n35j the device was damaged/deformed product - device is operable.The following information was provided by the initial reporter.The customer stated: "a defect on the connection interface of the injector was found before preparation.The claws at the connection are deformed.".

Manufacturer Narrative

H.6.Investigation: samples and photo received for investigation.Through visual inspection, it is noted that injector handles are displaced from their original location.The product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.It is important to grip the white injector components when engaging/ disengaging; do not grip the blue safety sleeve.If the safety sleeve grips become dislocated, the injector is activated causing needle exposure.To prevent damage to the handles of the safety sleeve, the injector must be removed by pulling it backwards and must not be forcibly engaged.The instructions for use must be carefully followed when using phaseal devices in order to avoid any damage to the product that may result in the device not functioning as intended.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.H3 other text : see h.10.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35J
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12861987
• MDR Text Key: 281156755
• Report Number: 3003152976-2021-00782
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1