MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Model Number 328418

Device Problem Defective Device (2588)

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

Event Date 04/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed.Due to the batch being unknown, no dhr review can be completed.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Root cause description: the root cause is undetermined.Rationale: based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that syringe 1.0ml 31ga 8mm ufii 10bag 500cs was damaged and had foreign matter.The following information was provided by the initial reporter: material no: 328418, batch no: unknown.It was reported that the needles are different lengths and not centered.Also, some of the needles do not work and seem to have an obstruction and are bent.

• Brand Name: SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11758471
• MDR Text Key: 248754409
• Report Number: 1920898-2021-00501
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328418
• Device Catalogue Number: 328418
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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