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

Catalog Number 306572

Device Problem Failure to Deliver (2338)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported while using bd¿ posiflush¿ saline xs 10 ml the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: following several problems encountered with pre-filled syringes of 0.9% sodium chloride (ref: (b)(4)), i would like to inform you of this recalcitrant anomaly that must have slipped through the cracks of your quality control / metrology process.In fact, we have noticed that some pre-filled syringes were extremely hard to push, (observed in particular on batches (b)(4) and 2062724) not allowing us to carry out a complete purge of the catheter and worrying us each time on the permeability of this one for information, this is 6/7 day care on a central venous catheter.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2153822.Medical device expiration date: 31-may-2025.Device manufacture date: 02-jun-2022.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: a device history record review was completed for provided material number 306572 and lot numbers 2153822 and 2062724.The review did not reveal any detected non-conformances during the production process that could have contributed to this incident.As samples were unavailable for this incident, a sample evaluation could not be performed.At this time, an exact cause could not be determined for the reported issue.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 while using bd¿ posiflush¿ saline xs 10 ml the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: following several problems encountered with pre-filled syringes of 0.9% sodium chloride (ref: 306572), i would like to inform you of this recalcitrant anomaly that must have slipped through the cracks of your quality control / metrology process.In fact, we have noticed that some pre-filled syringes were extremely hard to push, (observed in particular on batches n° 2153822 and 2062724) not allowing us to carry out a complete purge of the catheter and worrying us each time on the permeability of this one.For information, this is 6/7 day care on a central venous catheter.

• Brand Name: BD¿ POSIFLUSH¿ SALINE XS 10 ML
• 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: 16908389
• MDR Text Key: 315004510
• Report Number: 9616657-2023-00012
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306572
• Device Lot Number: 2062724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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