MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ SECONDARY SET C62; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515312

Device Problem Complete Blockage (1094)

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

Event Date 12/22/2021

Event Type  malfunction  

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 Description

It was reported that while injecting chemo into port the bd phaseal¿ secondary set c62 is discovered to have blockage.The following information was provided by the initial reporter: when the pharmacist attempts to inject the chemo via the port, unable to do so as the pharmacist describes as a blackage, which prevents the syringe from being depressed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2022-01-12.H6: investigation summary: sample and photo was provided to our quality team for investigation.Upon visual inspection, no damage or sign of obstruction observed.Functional evaluations were conducted, priming the set with saline, flow obstruction occurred.A device history review was performed and found no non-conformances associated with this issue during the production of lot ta12142, all product was manufactured according to specification.Product undergoes inspections throughout manufacturing according to procedure.All testing was reviewed for the reported lot, including leakage, torque, and inspection results with no issues identified related to the reported malfunction.Possible root cause is associated with an excess of solvent between phaseal connector and ¿y¿ port, causing an occlusion in the line.

Event Description

It was reported that while injecting chemo into port the bd phaseal¿ secondary set c62 is discovered to have blockage.The following information was provided by the initial reporter: when the pharmacist attempts to inject the chemo via the port, unable to do so as the pharmacist describes as a blackage, which prevents the syringe from being depressed.

• Brand Name: BD PHASEAL¿ SECONDARY SET C62
• 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: 13261870
• MDR Text Key: 285483326
• Report Number: 3003152976-2022-00001
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 02/22/2022

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
• Device Operator: Other
• Device Catalogue Number: 515312
• Device Lot Number: TA12142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 02/22/2022
• Supplement Dates FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1