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

Catalog Number 326631

Device Problem Material Separation (1562)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

B3.Date of event: unknown.The date received by manufacturer has been used for this field.D4.Medical device expiration date: unknown.H3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.

Event Description

It was reported that prior to use with bd ultra-fine¿ 3/10ml insulin syringe the stopper separated from plunger and remained in syringe.The following information was provided by the initial reporter, translated from japanese to english: this report is about a damaged stopper.When the plunger was pulled, the stopper stuck to the syringe, and the drug solution could not be filled.

Event Description

It was reported that prior to use with bd ultra-fine¿ 3/10ml insulin syringe the stopper separated from plunger and remained in syringe.The following information was provided by the initial reporter, translated from japanese to english: this report is about a damaged stopper.When the plunger was pulled, the stopper stuck to the syringe, and the drug solution could not be filled.

Manufacturer Narrative

H6: investigation summary the customer returned (1) 0.3ml 29 ga syringe, reporting stopper separates.The syringe was visually inspected and observed broken plunger tip that holds the stopper.Based on the sample returned, embecta was able to confirm the customer-indicated failure.Due to unknown batch number, no dhr can be completed.Based on the sample received, embecta was able to confirm the customer-indicated failure.Unable to perform review of the device history record and leading 2lean (l2l) due to lack of batch record information.Therefore, a definitive a definitive root-cause could not be determined.

• Brand Name: BD ULTRA-FINE¿ 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: 17222318
• MDR Text Key: 318303894
• Report Number: 1920898-2023-00410
• Device Sequence Number: 1
• Product Code: FMF
• 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: 09/07/2023

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/21/2023
• 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