MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE IB 25 TRAY 1000; SYRINGE WITH NEEDLE

Catalog Number	305536
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that when recapping the needle of a bd¿ syringe ib 25 tray 1000, the needle bent and pierced through the shield, resulted in needle stick injury.The staff member underwent blood work following facility protocol.The following information was provided by the initial reporter: ¿material no: 305536, batch no: 8205752.It was reported that when the staff member was recapping the needle after use, the needle bent and pierced the shield which resulted in a needle stick injury.The staff member underwent blood work following facility protocol.Information was received on follow up call with customer on 03/27.¿.
Additional Manufacturer Narrative
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 #8205752.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained 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.Based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that when recapping the needle of a bd¿ syringe ib 25 tray 1000, the needle bent and pierced through the shield, resulted in needle stick injury.The staff member underwent blood work following facility protocol.The following information was provided by the initial reporter: ¿ material no: 305536 batch no: 8205752.It was reported that when the staff member was recapping the needle after use, the needle bent and pierced the shield which resulted in a needle stick injury.The staff member underwent blood work following facility protocol.Information was received on follow up call with customer on 03/27.¿.

• Brand Name: BD SYRINGE IB 25 TRAY 1000
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8487397
• Report Number: 1920898-2019-00321
• Device Sequence Number: 1884541
• Product Code: FMF
• UDI-Device Identifier: 30382903055365
• UDI-Public: 30382903055365
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 305536
• Device Lot Number: 8205752
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other