MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGES 3/10ML; PISTON SYRINGE

Model Number	328431
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.
Event or Problem Description
It was reported that bd ultra-fine¿ insulin syringes 3/10ml experienced a case of a plunger that was loose/fell out/separated, and a case of hub separation from the device.The following information was provided by the initial reporter: consumer reported plunger cap was difficult to remove.Plunger rod detached from syringe.Needle hub separated and was stuck inside of the shield.Lot #: 1077626.Catalog #: 328431.Date of event: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-04-30.H6: investigation summary customer returned two syringes with 0.3ml graduation markings.No polybag was returned for identification.The first syringe had its needle shield and hub separate from the barrel.The hub has become lodged inside the shield.There is no damage to either the connector at the distal tip of the barrel or its respective needle hub.No signs of use and no other defects found.The remaining syringe was returned with its plunger cap and plunger rod removed from the body of the syringe.Mechanical testing was performed on the cap and rod.The cap remained in place when put back on the syringe and could likewise be removed without difficulty.Additionally, the plunger rod was returned to the syringe and moved inside the barrel.The plunger moved normally with a slight resistance as intended.It also would remain stationary if untouched.No problems were observed with either the plunger cap or rod.The second syringe was also subjected to shield pull force testing to ensure that its shield and hub were functioning as intended.The pull force required to remove the needle shield was 3.51 lbs.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.This sample did not test outside of the required range and did not disassemble during testing.Due to the batch being unknown, no dhr review can be completed.Based on the samples received, bd was unable to confirm the customer¿s indicated failure of the plunger rod separating.Based on the samples received, bd was unable to replicate or confirm the customer¿s indicated failure of the plunger cap not detaching as intended.Based on the samples received, bd was able to confirm the customer¿s indicated failure of needle hub separation in one of the two returned samples.Capa pr1630423 has been opened to address this issue h3 other text : see h10.
Event or Problem Description
It was reported that bd ultra-fine¿ insulin syringes 3/10ml experienced a case of a plunger that was loose/fell out/separated, and a case of hub separation from the device.The following information was provided by the initial reporter: consumer reported plunger cap was difficult to remove.Plunger rod detached from syringe.Needle hub separated and was stuck inside of the shield.Lot #: 1077626 catalog #: 328431 date of event: unknown.

• Brand Name: BD ULTRA-FINE INSULIN SYRINGES 3/10ML
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11742906
• Report Number: 1920898-2021-00490
• Device Sequence Number: 4268711
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: Other
• Device Model Number: 328431
• Device Catalogue Number: 328431
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1