MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 31GA 6MM; PISTON SYRINGE

Catalog Number 324911

Device Problem Material Separation (1562)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: lot #: 0139024 ¿ device expiration date: 05/31/2025 ¿ device manufacture date: 05/18/2020.Lot #: 1053427 ¿ device expiration date: 03/31/2026, device manufacture date: 02/22/2021.Lot #: 0006789 ¿ device expiration date: 01/31/2025 ¿ device manufacture date: 01/06/2020.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 3 bd syringe 0.5 ml 31 ga 6 mm hubs separated from the device.The following information was provided by the initial reporter: the consumer reported that the needle hub separated from the syringe and was stuck inside of the shield.Date of event: unknown, samples: available.

Event Description

It was reported that 3 bd syringe 0.5ml 31ga 6mm hubs separated from the device.The following information was provided by the initial reporter : the consumer reported that the needle hub separated from the syringe and was stuck inside of the shield.Date of event : unknown.Samples: available.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: (b)(6)2021.H.6.Investigation: customer returned (13) loose 0.5ml bd insulin syringes.Consumer reported that the needle hub separated from the syringe and was stuck inside of the shield.All 13 returned syringes were examined, and it was observed that 10 of the syringes exhibited a needle hub/shield assembly detached from the barrel.No damage to the barrel tips was observed (see attached photos).The remaining 3 syringes did not exhibit detached hub assemblies; removing the cannula shields from these 3 syringes did not result in hub separation.A review of the device history record was completed for batch# 0139024.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.A review of the device history record was completed for batch# 1053427.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 0006789.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Capa#1630423 was initiated.Root cause could not be determined.

• Brand Name: BD SYRINGE 0.5ML 31GA 6MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12269369
• MDR Text Key: 265177855
• Report Number: 1920898-2021-00850
• Device Sequence Number: 1
• Product Code: FMF
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324911
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1