MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE INJECTOR WITHOUT RUBBER STOPPER; PISTON SYRINGE

Catalog Number 301940

Device Problem Complete Blockage (1094)

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

Event Date 04/01/2022

Event Type  malfunction  

Manufacturer Narrative

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 syringe injector without rubber stopper the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: at about 10:00 a.M.On (b)(6) 2022, when a nurse used a 2ml syringe, she found that the needle of the syringe was blocked and the liquid could not be injected, so coc was needed.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed for provided material number 301940 and lot number 2107123.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, pictures were returned for evaluation by our quality engineer team; however, the pictures were unable to confirm the reported incident.At this time, an exact cause related to the manufacturing process could not be determined for this incident.

Event Description

It was reported while using bd syringe injector without rubber stopper the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: at about 10:00 a.M.On april 1, 2022, when a nurse used a 2ml syringe, she found that the needle of the syringe was blocked and the liquid could not be injected, so coc was needed.

• Brand Name: BD SYRINGE INJECTOR WITHOUT RUBBER STOPPER
• Type of Device: PISTON SYRINGE
• 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: 14197390
• MDR Text Key: 290156342
• Report Number: 3002682307-2022-00123
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/06/2022

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: Health Professional
• Device Catalogue Number: 301940
• Device Lot Number: 2107123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 06/06/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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