MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE, 3/10ML 31G X 8MM; PISTON SYRINGE

Model Number	928858
Medical Device Problem Codes	Break (1069); Failure to Deliver (2338)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that while using bd insulin syringe, 3/10ml 31g x 8mm the plunger was difficult to move and cannula broke off.There was no report of patient impact.The following information was provided by the initial reporter: hi we have a patient that uses our insulin syringes wic 654882 ndc 11917-0048-15.They have had about 2-5 in each of the last couple of boxes that have been defective.The plunger did not work, the needles broke were the common complaints.They are going to bring a couple in if you would like to investigate them.However, this does not seem to reflect high quality as advertised.
Event or Problem Description
It was reported that while using bd insulin syringe, 3/10ml 31g x 8mm the plunger was difficult to move and cannula broke off.There was no report of patient impact.The following information was provided by the initial reporter: hi we have a patient that uses our insulin syringes wic 654882 ndc 11917-0048-15.They have had about 2-5 in each of the last couple of boxes that have been defective.The plunger did not work, the needles broke were the common complaints.They are going to bring a couple in if you would like to investigate them.However, this does not seem to reflect high quality as advertised.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/13/2021.H.6.Investigation: customer returned (35) loose 3/10cc, 8mm syringes.Customer states that the plunger did not work, that the needles broke and that the needles were bending when inserted into the vial.All returned syringes were tested and all were able to draw and expel properly without any defects observed with the plunger rods.All returned syringes were examined and no broken cannula was observed.Thirty out of 35 returned syringes were tested for point geometry, lube, and cannula od.All observations fell within specifications.Unable to perform dhr check due to unknown lot number.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that while using bd insulin syringe, 3/10ml 31g x 8mm the plunger was difficult to move and cannula broke off.There was no report of patient impact.The following information was provided by the initial reporter: hi, we have a patient that uses our insulin syringes wic 654882 ndc 11917-0048-15.They have had about 2-5 in each of the last couple of boxes that have been defective.The plunger did not work, the needles broke were the common complaints.They are going to bring a couple in if you would like to investigate them.However, this does not seem to reflect high quality as advertised.

• Brand Name: BD INSULIN SYRINGE, 3/10ML 31G X 8MM
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11140998
• Report Number: 1920898-2021-00013
• Device Sequence Number: 13662232
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: (01)00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 04/12/2021; 07/15/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 04/18/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1