MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS SYRINGE 10ML LL; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 07/03/2023

Event Type  malfunction  

Event Description

It was reported that prior to use with 6 bd posiflush¿ xs syringe 10ml ll the unit packages were damaged, thus affecting sterility.The following information was provided by the initial reporter: the customer stated, "patient advised that they received 6 broken/damaged posiflushs".

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.

Event Description

It was reported that prior to use with 6 bd posiflush¿ xs syringe 10ml ll the unit packages were damaged, thus affecting sterility.The following information was provided by the initial reporter: the customer stated, ¿patient advised that they received 6 broken/damaged posiflushs.'.

Manufacturer Narrative

H.6.Investigation summary: to aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.The picture sample displayed a tear in the top web of the unit package.A review of the manufacturing engineering system (mes) found no issues at the multivac during the manufacture of this lot, however, there were entries relating to the packaging station.It is most likely that the observed defect resulted from damage to the shelf carton during the packaging process, which in turn damaged the blister packages.Additional information regarding the packaging details was requested; however, the information was unavailable.If additional feedback becomes available, we would like the opportunity to re-evaluate.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: BD POSIFLUSH¿ XS SYRINGE 10ML LL
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17390625
• MDR Text Key: 319706285
• Report Number: 9616657-2023-00025
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/04/2023

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
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 2293101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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