MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Catalog Number	928851
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/07/2019
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 and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
Material no.928851, batch no.Unknown.It was reported that during use of the syringe 0.5ml 29ga 1/2in 10bag 500 pl/wg the needle was sticking through shield and stuck consumer on his left thumb.Little bleeding from needle stick.Did not seek medical attention.Consumer did perform first aid at home.The following information was provided by the initial reporter: consumer reported, needle sticking through shield stuck his left thumb got a little blood from the stick.Did not seek medical.Performed some first aid at home, says his thumb is fine.Incident date: (b)(6) 2019, item: 29g, 12.7, (b)(4) units/928851 did not have bag or box to provide any additional information.
Additional Manufacturer Narrative
Customer returned (1) loose 1/2cc syringe.Customer states that the needle was sticking through the shield, it stuck his thumb, and got a little blood.The returned syringe was examined and exhibited the cannula through the shield, exposing the cannula, which could lead to a needle stick.Unable to perform dhr check for cannula through shield, needle stick (before use) and harm/bleeding due to unknown lot number.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure after visual inspection of the 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.Process: ¿ racks loaded with hubs travel down a conveyor towards the cannulator.¿ they approach the cannulator turning horizontally in order to receive cannula.¿ racks pass under mars magnet straightening the cannula in the hubs.The rack passes under two ultraviolet lamps, which causes the adhesive to cure.¿ then the racks go to the shielder with the use of linear motion.The rack locater positions the racks while getting shielded.¿ the parts are first inspected with an angularity camera, and if the angle of the cannula is too great or there is nothing on that pin, the part is not shielded.¿ the finished product pick and place head won¿t pick it up in the gripper as it is gripping the shield for pick up.Investigation: ¿ reviewed the logbooks and l2l for machine adjustment on the process.Did not find any adjustments.
Event or Problem Description
Material no.928851 batch no.Unknown.It was reported that during use of the syringe 0.5ml 29ga 1/2in 10bag 500 pl/wg the needle was sticking through shield and stuck consumer on his left thumb.Little bleeding from needle stick.Did not seek medical attention.Consumer did perform first aid at home.The following information was provided by the initial reporter: consumer reported, needle sticking through shield stuck his left thumb got a little blood from the stick.Did not seek medical.Performed some first aid at home, says his thumb is fine.Incident date: (b)(6) 2019, item: 29g, 12.7, 50units/928851.Did not have bag or box to provide any additional information.

• Brand Name: SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9218058
• Report Number: 1920898-2019-01174
• Device Sequence Number: 16832130
• Product Code: FMF
• UDI-Device Identifier: 00311917014890
• UDI-Public: 00311917014890
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: Lay User/Patient
• Device Catalogue Number: 928851
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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