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

Catalog Number 306546

Device Problem Defective Component (2292)

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

Event Date 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was completed for provided material number: 306546 and lot number: 2215606.The review did not reveal any possible non-conformances during the production process which could have contributed to the reported incident.As no pictures or physical samples were available, our quality team was unable to perform a thorough sample analysis.If samples become available, we would appreciate the opportunity to review them and perform a revised investigation.Based on the provided feedback, it is most probable that this incident resulted from customer misuse.Posiflush syringes are pre-filled single use syringes intended for flushing.Pre-filled and conventional syringes have different purposes.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.

Event Description

It was reported that an unspecified amount of bd posiflush¿ normal saline syringes had their stoppers separate from their plungers during use while pulling back on them.The following information was provided by the initial reporter: "i was noticing that some of the plungers separate when pulling back on them.I thought it was from pulling on them too much when drawing back on a line, but it has happened quite a few times over a period of time".

Manufacturer Narrative

H6: investigation summary: a device history record review was completed for provided material number 306546 and lot number 2215606.The review did not reveal any possible non-conformances during the production process which could have contributed to the reported incident.To aid in the investigation of this issue, one picture sample was provided for evaluation by our quality engineer team.Through examination of the picture alone, we were unable to determine if the product was defective.However, based on the provided feedback, it is most probable that this incident resulted from customer misuse.Posiflush syringes are pre-filled single use syringes intended for flushing.Pre-filled and conventional syringes have different purposes.

Event Description

It was reported that an unspecified amount of bd posiflush¿ normal saline syringes had their stoppers separate from their plungers during use while pulling back on them.The following information was provided by the initial reporter: "i was noticing that some of the plungers separate when pulling back on them.I thought it was from pulling on them too much when drawing back on a line, but it has happened quite a few times over a period of time".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16534666
• MDR Text Key: 311327464
• Report Number: 9616657-2023-00006
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

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: 306546
• Device Lot Number: 2215606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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