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

Catalog Number 326666

Device Problem Crack (1135)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

It was reported while using bd ultra-fine¿ 1/2ml insulin syringe 29g the product was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a damaged barrel.According to the user's report, the barrel was found to be cracked.

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-may-2023.H6: investigation summary: the customer returned (1) 0.5ml 29ga syringe, reporting barrel damaged/cracked.The syringe was visually examined and observed a damaged/cracked barrel.Based on the sample received and visual examination, embecta was able to confirm the reported failure.Due to the batch being unknown, no dhr review can be completed.A definitive a definitive root-cause could not be determined.H3 other text : see h10.

Event Description

It was reported while using bd ultra-fine¿ 1/2ml insulin syringe 29g the product was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about a damaged barrel.According to the user's report, the barrel was found to be cracked.

• Brand Name: BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE 29G
• 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: 16668666
• MDR Text Key: 312675808
• Report Number: 1920898-2023-00190
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903266661
• UDI-Public: (01)00382903266661
• 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: 07/13/2023

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: 326666
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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