MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Catalog Number 328468

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

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 an unspecified number of syringe 0.5ml 31ga 8mm ufii 10bag 500cs experienced the cannula breaking off or pulling out during use, and serious injury in the form of medical intervention.The consumer stated that the cannula broke off beneath the skin and they were unable to pull it out.The consumer sought urgent care, but there is no additional information regarding the outcome of the medical intervention.The following information was provided by the initial reporter: material no: 328468 ; batch no: 8232928.Verbatim: issue(s): needle break off in site (ab) during injection.Does not reuse needles.Unable to pull out on her own.Consumer stated going to the urgent care now.Can see the needle under her skin.Lot #: 8232928.Item #: 328468.Date of event: (b)(6) 2019.

Manufacturer Narrative

H.6.Investigation: customer returned one (1) loose 0.5ml bd insulin syringe.Consumer reported needle break off in site (ab) during injection.The returned syringe was examined, and it was observed that the cannula was broken.No evidence of manufacturing defect was observed on the sample.The hub-end of the cannula appeared to have been bent prior to breaking, suggesting a bending and re-straightening mode of failure.Since the syringe was returned after use, and no manufacturing defects were observed, the probable cause of the broken cannula is user error when using the syringe.A review of the device history record was completed for batch# 8232928.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200772181] noted for adhesive on cannula.There was one (1) notification [200772622] noted that did not pertain to the complaint.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of syringe 0.5ml 31ga 8mm ufii 10bag 500cs experienced the cannula breaking off or pulling out during use, and serious injury in the form of medical intervention.The consumer stated that the cannula broke off beneath the skin and they were unable to pull it out.The consumer sought urgent care, but there is no additional information regarding the outcome of the medical intervention.The following information was provided by the initial reporter: material no: 328468; batch no: 8232928.Verbatim: issue(s): needle break off in site (ab) during injection.Does not reuse needles.Unable to pull out on her own.Consumer stated going to the urgent care now.Can see the needle under her skin.Lot #: 8232928; item #: 328468; date of event: (b)(6) 2019.

• Brand Name: SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9527197
• MDR Text Key: 183906461
• Report Number: 1920898-2019-01478
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 328468
• Device Lot Number: 8232928
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other