MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 2ML SYRINGE; PISTON SYRINGE

Catalog Number 303055

Device Problem Complete Blockage (1094)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 2 cases of bd 2ml syringes were clogged.The following information was provided by the initial reporter: unable to push medications through the needle.

Event Description

It was reported that 2 cases of bd 2ml syringes were clogged.The following information was provided by the initial reporter: unable to push medications through the needle.

Manufacturer Narrative

Investigation summary a device history record review was completed for provided material number 303055 and lot number 2007149.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.As samples were unavailable for return, twenty retained samples were obtained for evaluation by our quality engineer team.Upon examination, none of the retained samples showed any signs of clogged needle.Based on the investigation results, a cause related to the needle manufacturing process could not be determined at this time.Needles are examined for occlusion as part of the in-process inspections after assembly.In certain circumstances, the medication used can become deposited inside of the cannula, causing the needle to become occluded due to crystallization or other solubilization effects.Occlusion is most likely to occur if a drug remains in the needle for an extended period of time.

• Brand Name: BD 2ML SYRINGE
• 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: 15704959
• MDR Text Key: 306996107
• Report Number: 3002682307-2022-00291
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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: Other
• Device Catalogue Number: 303055
• Device Lot Number: 2007149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/22/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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