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

Catalog Number 306575

Device Problem Defective Component (2292)

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

Event Date 05/27/2023

Event Type  malfunction  

Event Description

It was reported while using bd posiflush¿ normal saline syringe the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: unable to empty syringe, plunger got stuck while in use.During use on patient the plunger suddenly was not possible to accelerate/push forward.

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.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 26-june-2023.H6: investigation summary a device history record review was completed for provided material number 306575 and lot number 2348156.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, one (1) used sample and another thirteen (13) unopened samples were returned for evaluation by our quality engineer team.A silicone distribution test was performed and all of the returned samples were found to have results within specifications.Based on these results, a cause related to the manufacturing process could not be determined for this incident.

Event Description

It was reported while using bd posiflush¿ normal saline syringe the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: unable to empty syringe, plunger got stuck while in use.During use on patient the plunger suddenly was not possible to accelerate/push forward.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• 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 ; 8448235433
• MDR Report Key: 17193352
• MDR Text Key: 317828367
• Report Number: 3002682307-2023-00168
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065752
• UDI-Public: (01)00382903065752
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306575
• Device Lot Number: 2348156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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