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

Catalog Number 306572

Device Problem Short Fill (1575)

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

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd¿ posiflush¿ saline xs 10 ml the prefilled syringe had the incorrect volume.There was no report of patient impact.The following information was provided by the initial reporter: posiflush10ml (b)(4) nacl prefilled syringe was removed from it's sealed packaging just prior to use.The syringe should have been prefilled with 10ml of nacl but was found to have just under 1ml of nacl in it with the remainder being air.

Manufacturer Narrative

D10: device available for eval yes.D10: returned to manufacturer on: 19jul2023.H6: investigation summary a device history record review was completed for provided material number 306572 and lot number 3061553.The review did not reveal any non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one (1) syringe was returned for evaluation by our quality team.Through examination of the syringe, incorrect fill was identified.An air leak test was performed on the syringe barrel and the results showed a failure.Visual inspection of the barrel confirmed a sink in the luer component.A service was previously completed on the applicable mold component.A current sample was obtained from this mold component for analysis.The current sample was found to pass the air leak test.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 while using bd¿ posiflush¿ saline xs 10 ml the prefilled syringe had the incorrect volume.There was no report of patient impact.The following information was provided by the initial reporter: posiflush10ml 0.9% nacl prefilled syringe was removed from it's sealed packaging just prior to use.The syringe should have been prefilled with 10ml of nacl but was found to have just under 1ml of nacl in it with the remainder being air.

• 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: 17258462
• MDR Text Key: 318516871
• Report Number: 9616657-2023-00016
• 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: 07/21/2023

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: 3061553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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