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

Model Number 328466

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2022

Event Type  malfunction  

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 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 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".

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.

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 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
• Type of Device: 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
• MDR Text Key: 308865829
• Report Number: 1920898-2023-00025
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: 00382908466035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1