MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG; PISTON SYRINGE

Catalog Number 324909

Device Problem Material Puncture/Hole (1504)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint for cannula through shield and needle stick (after use) on lot # 8337695.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 8337695.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.As no samples and/or photo(s) were received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that after injection, while recapping the needle went through the shield resulting in needle stick injury with a bd syringe 0.3ml 31ga 6mm whole unit 10bag.The following information was provided by the initial reporter: (1 of 2) it was reported by the consumer that after injecting his cat, he was recapping the needle, the needle went through the shield resulting in a needle stick to the consumer.No medical attention received from this incident.

Event Description

It was reported that after injection, while recapping the needle went through the shield resulting in needle stick injury with a bd syringe 0.3ml 31ga 6mm wholeunit 10bag.The following information was provided by the initial reporter: (1 of 2) it was reported by the consumer that after injecting his cat, he was recapping the needle, the needle went through the shield resulting in a needle stick to the consumer.No medical attention received from this incident.

Manufacturer Narrative

The following fields were updated with additional information, due to samples received: device available for eval? yes returned to manufacturer on: 2019-08-22.Investigation summary: level b investigation complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint for cannula through shield and needle stick (after use) on lot # 8337695.Investigation summary: samples for both pr-1092234 and pr-1092275 were returned.Customer returned one (1) loose 31g x 6mm, 0.3ml bd insulin syringe.Consumer reported syringe went sideways thru shield stuck finger recapping.The returned sample was examined, and it was observed that the needle-hub/shield assembly was separated from the syringe barrel; no damage to the barrel tip was observed.Issues regarding needle-hub separation were captured in pr-1092275.As no issues regarding cannula through shield or needle stick were observed, the alleged issues could not be confirmed.A review of the device history record was completed for batch# 8337695.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200802305] noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failures complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issues are unconfirmed.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

• Brand Name: BD SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8896587
• MDR Text Key: 154450985
• Report Number: 1920898-2019-00813
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: 00382903249091
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 324909
• Device Lot Number: 8337695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other