MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2"; PISTON SYRINGE

Catalog Number 326631

Device Problem Material Separation (1562)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown h.3.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 ultra-fine¿ 3/10ml insulin syringe 29g x 1/2" the hub separated from the device.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the needle hub came off.The needle hub came off together with the cap when checking before use.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 2234021.D4: medical device expiration date: 22-aug-2023.H4: device manufacture date: 30-sep-2027.D10: device available for eval yes, d10: returned to manufacturer on: 29-aug-2023.H6: investigation summary customer returned (1) 0.3ml 29g 12.7mm syringe in an open polybag from the lot# 2234021.The customer reported that the needle hub came off.The needle hub came off together with the cap when checking before use.The returned sample visually examined and observed no issues with needle hub separates.No issues were observed with needle hub during shield attachment/detachment.A review of the device history record was completed for batch# 2234021.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.Unconfirmed: based on the return samples, embecta was not able to confirm the customer indicated issue.Root cause cannot be determined as the issue is unconfirmed.

Event Description

It was reported while using bd ultra-fine¿ 3/10ml insulin syringe 29g x 1/2" the hub separated from the device.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the needle hub came off.The needle hub came off together with the cap when checking before use.

• Brand Name: BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE 29G X 1/2"
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17495317
• MDR Text Key: 320920572
• Report Number: 1920898-2023-00549
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903266319
• UDI-Public: (01)00382903266319
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/19/2023

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: 326631
• Device Lot Number: 2234021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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