MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL; PISTON SYRINGE

Model Number 328512

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the syringe 0.3ml 31ga 8mm 10bag 500 wal experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.328512, batch no.9168970.Verbatim: issue: pet owner reported when she opened the package one of the syringe barrel was filthy and dirty inside the barrel.This happened couple of days ago.She stated she uses the 31g, 8mm, 3/10 syringes for her pet.Sample available.Item# 328512, lot# 9168970.Pet owner always uses the new needle for its injection.She visually test the needle to see if it is straight.Offered to send the replacement, she refused to get the replacement.

Manufacturer Narrative

Investigation: no samples (including photos) were returned as of (b)(6) 2020 therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9168970.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for fm in barrel.

Event Description

It was reported that the syringe 0.3ml 31ga 8mm 10bag 500 wal experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: material no.328512 batch no.9168970.Verbatim: issue: pet owner reported when she opened the package one of the syringe barrel was filthy and dirty inside the barrel.This happened couple of days ago.She stated she uses the 31g, 8mm,3/10 syringes for her pet.Sample available.Item# 328512, lot# 9168970.Pet owner always uses the new needle for its injection.She visually test the needle to see if it is straight.Offered to send the replacement, she refused to get the replacement.

• Brand Name: SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9527728
• MDR Text Key: 193653339
• Report Number: 1920898-2019-01480
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311786
• UDI-Public: 00681131311786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• 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,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328512
• Device Catalogue Number: 328512
• Device Lot Number: 9168970
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• 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
• Patient Outcome(s): Other