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

Model Number 328512

Device Problems Failure to Deliver (2338); Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

"medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).".

Event Description

It was reported that 3 syringe 0.3ml 31ga 8mm 10bag 500 wal were damaged and unable to aspirate during use.The following was reported by the initial reporter: "it was reported that the consumer had difficulty drawing up the medication with three syringes.Also, the plunger bent and was very weak/thin.Verbatim: relion consumer reported difficulty drawing up his medication with 3 syringes.Stated the plunger also seems to bend and is very weak and thin on these syringes.Stated this product is a mess and he will not be using them anymore.Request refund.Lot #0160001, cat # 328512 date of event: (b)(6) 2021 for all issues reported samples: yes, sending mail kit.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/9/2021.H.6.Investigation: customer returned (2) 3/10cc, 8mm relion, bd manufactured syringes along with a syringe and a poly bag that is not bd manufactured product.Customer states that the plunger bent, was very weak/thin and that they had difficulty drawing up the medication with three syringes.The returned bd manufactured syringes were tested and both were able draw and expel properly without any observed defects.A review of the device history record was completed for batch# 0160001.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h.10.

Event Description

It was reported that 3 syringe 0.3ml 31ga 8mm 10bag 500 wal were damaged and unable to aspirate during use.The following was reported by the initial reporter: "it was reported that the consumer had difficulty drawing up the medication with three syringes.Also, the plunger bent and was very weak/thin.Verbatim: relion consumer reported difficulty drawing up his medication with 3 syringes.Stated the plunger also seems to bend and is very weak and thin on these syringes.Stated this product is a mess and he will not be using them anymore.Request refund.Lot #0160001, cat # 328512.Date of event: (b)(6) 20 21 for all issues reported samples: yes, sending mail kit".

• 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
• MDR Report Key: 11234030
• MDR Text Key: 230101071
• Report Number: 1920898-2021-00114
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311786
• UDI-Public: 00681131311786
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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: Lay User/Patient
• Device Model Number: 328512
• Device Catalogue Number: 328512
• Device Lot Number: 0160001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1