MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS; PISTON SYRINGE

Model Number 328466

Device Problems Leak/Splash (1354); 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 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

"date of event: unknown.The date received by manufacturer has been used for this field.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 8 syringe 0.5ml 30ga 1/2in uf 10bag 500cs were damaged during use.The following was reported by the initial reporter: "it was reported that the barrel split down the middle and the needle is missing from the syringe.Also, the needle is bent and the needle is curved at the shaft.Verbatim: consumer reported barrel split down the middle.Needle missing from syringe, hub is intact.Needle bent.Needle curved at the shaft.Issues involve 8 syringes.Lot #: 0252891, catalog #: 328466, date of event: unknown, samples: available - 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: 3/18/2021.H.6.Investigation: customer returned a total of nine syringes with 0.5ml graduation markings.No pouch was returned for identification.Two of the nine syringes featured damage to their barrels.One was had fractured across the barrel itself, separating the barrel into two different segments, while the other is broken across one side of its flange.High stresses sufficient to crush or bend the syringes may have been applied.One of the nine syringes features a broken needle.The needle is broken at the distal tip of the barrel of the syringe.The needle may have been torqued to one side while in a vial.Accidental stresses on the needles during use may have been significant enough for it to fracture.Five of the nine syringes feature bent needles.The exact location of the bend varies, but is generally close to the middle of the needle.Much like with the broken needle, these needles may have been torqued to one side while in a vial, with the stresses being applied toward the midpoint and tip of the needle as opposed to the base.Accidental stresses on the needles during use may have been significant enough for them to bend.The remaining syringe features no observable damage.A review of the device history record was completed for batch# 0252891.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.Based on the samples available, bd was able to confirm that two of the nine syringes returned featured damage to their barrels, that the one of the nine syringes¿ needles were missing as it had broken off from the barrel, and was able to confirm that five of the nine syringes featured bent needles.The root cause of the needles breaking may be accidentally torquing the syringe while inside of an associated vial, placing sufficient stress on the body of the needle in order for them to bend/break.L2l maintenance dispatch for damaged barrels generated on 02oct2020 at the printer operation.The blank barrels transfer down one rail into a indexer and on to an additional rail prior to going into the printing machine.If a barrel isn¿t feeding into the indexer correctly, it could cause a jam at the indexer and could damage the syringe.H3 other text : see h.10.

Event Description

It was reported that 8 syringe 0.5ml 30ga 1/2in uf 10bag 500cs were damaged during use.The following was reported by the initial reporter: "it was reported that the barrel split down the middle and the needle is missing from the syringe.Also, the needle is bent and the needle is curved at the shaft.Verbatim: consumer reported barrel split down the middle.Needle missing from syringe, hub is intact.Needle bent.Needle curved at the shaft.Issues involve 8 syringes.Lot #: 0252891catalog #: 328466date of event: unknown samples: available - sending mail kit".

• Brand Name: SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11381373
• MDR Text Key: 233771100
• Report Number: 1920898-2021-00224
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: 00382908466035
• 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: 04/16/2021

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: 328466
• Device Catalogue Number: 328466
• Device Lot Number: 0252891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1