MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ SPIKE CONNECTOR C180J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515322

Device Problem Break (1069)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

It was reported while using bd phaseal¿ spike connector c180j the spike was found to be broken.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: after the end of administration, the root of the spike inserting a saline bag was broken.

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary two photos were provided to our quality team for investigation.Through visual inspection, the spike is observed to be disconnected from the connector.It is noted there is no visible trace of the solvent used to adhere the spike to the connector.A device history review was performed for reported lot 2105213, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of the same lot were used for additional evaluation.The product was visually inspected, no defects were observed.Upon performing assembly force testing, all product met required specifications.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.Although we could not identify a direct problem, it was determined this incident was likely related to the operator not properly applying the solvent used to adhere the components during assembly.

Event Description

It was reported while using bd phaseal¿ spike connector c180j the spike was found to be broken.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: after the end of administration, the root of the spike inserting a saline bag was broken.

• Brand Name: BD PHASEAL¿ SPIKE CONNECTOR C180J
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13869331
• MDR Text Key: 288212431
• Report Number: 3003152976-2022-00114
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515322
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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