MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326638

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

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¿ ii 3/10ml insulin syringe there was a mix of products.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the user's verbatim report is that needle lengths were different.

Event Description

It was reported while using bd ultra-fine¿ ii 3/10ml insulin syringe there was a mix of products.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the user's verbatim report is that needle lengths were different.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 26apr2023 h6: investigation summary samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h.10.

• Brand Name: BD ULTRA-FINE¿ II 3/10ML INSULIN SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16770827
• MDR Text Key: 313597632
• Report Number: 1920898-2023-00237
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903266388
• UDI-Public: (01)00382903266388
• 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: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326638
• Device Lot Number: 2087442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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