MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA; PISTON SYRINGE

Model Number 329461

Device Problems Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the syringe 0.5ml 28ga 1/2in bls 500cas ca experienced the needle piercing through the shield after re-capping and was involved in a needle stick injury to the hcp or care giver after use.The reporter stated that after the needle had been used on a patient, the needle pierced through the cap, and stuck the hcp or device operator.The hcp/device operators received testing for (b)(6).The results of the testing have not been specified.The following information was provided by the initial reporter: material no: 329461, batch no: 8337721.Verbatim: the caller stated after using the needle on a patient, they put the cap back on the needle and the needle went through the cap sticking the caller in the finger.

Manufacturer Narrative

H.6.Investigation: customer returned (1) loose 1/2cc syringe.Customer states that the needle went through the cap stick the staff member in the finger when she was putting the cap back on the needle.The returned syringe was examined and exhibited the cannula through the shield, exposing the cannula, which could lead to a needle stick.A review of the device history record was completed for batch# 8337721.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200805366] noted that did not pertain to the complaint.After visual inspection of the photo sample, we would confirm that it is cannula through shield and happened after getting cannulated, passed the pim inspection for cannula angularity.It must have happened during the process of shielding.Reviewed the logbooks and l2l for machine adjustment on the process.Did not find any adjustments.Also did not have any notifications pertaining to cannula through shield.Root cause cannot be determined for this complaint.As per the customer, "the needle went through the cap stick the staff member in the finger when she was putting the cap back on the needle." a probable root cause for the needle stick is reshielding by the customer.¿ h3 other text : see h.10.

Event Description

It was reported that the syringe 0.5ml 28ga 1/2in bls 500cas ca experienced the needle piercing through the shield after re-capping and was involved in a needle stick injury to the hcp or care giver after use.The reporter stated that after the needle had been used on a patient, the needle pierced through the cap, and stuck the hcp or device operator.The hcp/device operators received testing for hiv and hepatitis.The results of the testing have not been specified.The following information was provided by the initial reporter: material no.: 329461, batch no.: 8337721.Verbatim: the caller stated after using the needle on a patient, they put the cap back on the needle and the needle went through the cap sticking the caller in the finger.

• Brand Name: SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9641004
• MDR Text Key: 183516991
• Report Number: 1920898-2020-00048
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 329461
• Device Catalogue Number: 329461
• Device Lot Number: 8337721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other