MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Defective Component (2292)

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

Event Date 03/24/2023

Event Type  malfunction  

Event Description

It was reported, that 2 of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% plunger movement was difficult.The following information was provided by the initial reporter, translated from french to english: 2 parents who reported, that when they use the syringe to flush their child's catheter, there is a significant resistance of the syringe which does not deliver the physiological serum in a fluid and simple way.Parents are afraid to press too hard and cause a problem with the catheter.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 2188694.D.4.Medical device expiration date: 30-jun-2025.H.4.Device manufacture date: 07-jul-2022.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12-april-2023.H6: investigation summary a device history record review was completed for provided material number 306572 and lot number 2188694 and 2249292.The review did not reveal any non-conformances that could have contributed to the reported incident.To aid in the investigation of this issue, two (2) samples from lot number 2188694 and four (4) samples from lot number 2249292 were returned for evaluation by our quality engineer team.All of the samples returned had less than 2ml of saline remaining.Testing was completed on each of the samples; however, no difficulties with plunger movement were identified.

Event Description

It was reported that 2 of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% plunger movement was difficult.The following information was provided by the initial reporter, translated from french to english: 2 parents who reported that when they use the syringe to flush their child's catheter, there is a significant resistance of the syringe which does not deliver the physiological serum in a fluid and simple way parents are afraid to press too hard and cause a problem with the catheter.

• Brand Name: BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
• 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: 16740468
• MDR Text Key: 313615387
• Report Number: 9616657-2023-00009
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: 2249292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• 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