MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928854
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 0.5ml 30ga 8mm 10bag 500 pl/wg needle hub separated on 9 occasions.The following information was provided by the initial reporter: material no.928854, batch no.9324122.It was reported that 9 needle hubs separated from syringes.
Event or Problem Description
It was reported that syringe 0.5ml 30ga 8mm 10bag 500 pl/wg needle hub separated on 9 occasions.The following information was provided by the initial reporter: material no.928854 batch no.9324122.It was reported that 9 needle hubs separated from syringes.
Additional Manufacturer Narrative
H6: investigation summary: customer returned nine (9) loose 0.3ml insulin syringes from lot 9324122.Consumer reported needle comes off on 9 syringe when remove needle shields.All 9 returned syringes were examined, and it was observed that all 9 exhibited a needle hub/shield assembly separated from the barrel; only 5 separated hub assemblies were returned, and no damage to the barrel tips was observed.A review of the device history record was completed for batch # 9324122 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200865195] noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure.He device history (dhr) for batch 9324122 was reviewed and zero quality notifications were written for issues relating to the assembled syringe defect.The syringes were assembled from 05feb2020 to 08feb2020.During the manufacturing process, the following inspections are completed on regular intervals: 1.Visual inspection every hour: needle assembly not fully seated or improperly seated on barrel tip: hub to barrel gap measurement (pin gauge used when deviation is suspected).2.Visual inspection every hour: missing component.3.Visual inspection every hour: damaged / defective components.4.Functional inspection every 2 hours: hub removal force.If a defect is found during an inspection a quality notification is initiated.Maintenance dispatch (l2l) was reviewed, and no dispatches were created from 05feb2020 to 08feb2020 that would cause the needle assembly unit to become unattached.Root cause: root cause for this defect cannot be determined.Dhr, l2l dispatches, logbook entries were looked at, nothing was found pertaining to this defect.Capa1630423 has been opened to address this issue.H3 other text : see h.10.

• Brand Name: SYRINGE 0.5ML 30GA 8MM 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: 10782885
• Report Number: 1920898-2020-01530
• Device Sequence Number: 4012038
• Product Code: FMF
• UDI-Device Identifier: 00311917025285
• UDI-Public: 00311917025285
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 928854
• Device Catalogue Number: 928858
• Device Lot Number: 9324122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1