MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE VET SYRINGE 0.3ML X 29G X 12.7MM; PISTON SYRINGE

Model Number 323000

Device Problem Material Separation (1562)

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

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 bd vet syringe 0.3ml x 29g x 12.7mm hub separated from the device.The following information was provided by the initial reporter :   the consumer reported the needles are dull, will not penetrate the skin and the needle hub separated.  date of event: unknown.Samples: available.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-05-24.Investigation summary customer returned (5) 29gx12.7mm, 0.3ml bd insulin syringes in an opened polybag from 0174596.The customer reported syringe needles are dull, will not penetrate the skin, and needle hub separated and stayed inside of the shield.All 5 returned samples were examined, and it was observed that 1 syringe exhibited a needle hub/shield assembly separated from the barrel.No damage to the barrel tip was observed.The other 4 samples did not exhibit hub separation; removing the cannula shields from these syringes did not result in hub separation.The other 4 samples were tested for needle length, point geometry, outer diameter and lube coverage.The following was observed (specs: outer diameter for 29g cannula: 0.0130¿- 0.0135¿): data: point outer diameter (in.) lube sample 1 good, 0.0133.Good, sample 2 good, 0.0134.Good, sample 3 good, 0.0133.Good, sample 4 good, 0.0133.Good, all observations tested within specification.No defects were observed.A review of the device history record was completed for batch # 0174596 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure (hub separates).Capa pr1630423 has been opened to address this issue.

Event Description

It was reported that 1 bd vet syringe 0.3ml x 29g x 12.7mm hub separated from the device.The following information was provided by the initial reporter :   the consumer reported the needles are dull, will not penetrate the skin and the needle hub separated.  date of event: unknown, samples: available.

• Brand Name: VET SYRINGE 0.3ML X 29G X 12.7MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11963237
• MDR Text Key: 257409944
• Report Number: 1920898-2021-00648
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 0174596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1