MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Model Number	328466
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2022
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.
Event or Problem Description
It was reported that the bd insulin syringe with the bd ultra-fine¿ needle pierced through the shield after the consumer recapped it.This occurred with 2 needles.The following information was provided by the initial reporter: "consumer reported gest diabetic reshielded syringe after injection and stuck her finger when needle went thru needle shield.2 times, 2 different syringes from this box.Advised caller to not reshield the syringes".
Event or Problem Description
It was reported that the bd insulin syringe with the bd ultra-fine¿ needle pierced through the shield after the consumer recapped it.This occurred with 2 needles.The following information was provided by the initial reporter: "consumer reported gest diabetic reshielded syringe after injection and stuck her finger when needle went thru needle shield.2 times, 2 different syringes from this box.Advised caller to not reshield the syringes".
Additional Manufacturer Narrative
Investigation summary.No samples including photos were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: h6: investigation summary customer returned 23 used syringes 0.5ml 30ga with no polybag.It was reported by the consumer that needle went through shield and cause needle stick twice.All the syringes were visually inspected and was verified that only one of the returned syringes has the needle sticking out through the shield.No issues were found on other 22 syringes.Needle stick could have happened because the cannula was through the shield.Due to the batch being unknown, no dhr review can be completed.Based on the samples received, embecta was able to confirm the customer¿s indicated failure.No root cause can be determined at this time.
Event or Problem Description
It was reported that the bd insulin syringe with the bd ultra-fine¿ needle pierced through the shield after the consumer recapped it.This occurred with 2 needles.The following information was provided by the initial reporter: "consumer reported gest diabetic reshielded syringe after injection and stuck her finger when needle went thru needle shield.2 times, 2 different syringes from this box.Advised caller to not reshield the syringes".

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16251035
• Report Number: 1920898-2023-00025
• Device Sequence Number: 20171328
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: 00382908466035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2023

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: 328466
• Device Catalogue Number: 328466
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/08/2023; 05/04/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/23/2023; 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown