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

Catalog Number 306573

Device Problem Material Separation (1562)

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

Event Date 11/05/2022

Event Type  malfunction  

Event Description

It was reported that the piston detached from the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% plunger during use.The following information was provided by the initial reporter: "the piston was detached from the plunger when pulling".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: unknown.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 the piston detached from the bd posiflush¿ sp pre-filled flush syringe nacl 0.9% plunger during use.The following information was provided by the initial reporter: "the piston was detached from the plunger when pulling.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 12-dec-2022.H6: investigation summary a device history record review was completed for provided material number 306573 and lot number 1279175.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, the affected sample was returned for evaluation by our quality engineer team.Through examination of the sample, the plunger rod appeared damaged at the threads.The damaged plunger threads most likely resulted during the plunger assembly process.During assembly, the plunger is assembled (twisted) into the stopper by pressure.If the machinery is not well adjusted, the plunger rod may become damaged.Based on the preventive measures in place, we believe this was an isolated incident with an unlikely chance of recurrence.H3 other text : see h10.

• Brand Name: BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15890669
• MDR Text Key: 307105015
• Report Number: 3002682307-2022-00317
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065738
• UDI-Public: (01)00382903065738
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K161552
• 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: 01/10/2023

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: 306573
• Device Lot Number: 1279175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2022
• Initial Date FDA Received: 11/30/2022
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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