MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 31GA 8MM; PISTON SYRINGE

Model Number	928857
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: unable to perform complaint lot history check for needle hub separates due to unknown lot number.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, needle hub seprates) was captured and addressed.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.Unable to perform a dhr review for needle hub separates due to unknown lot number.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 or Problem Description
It was reported that the hub separated from device with a bd syringe 0.5ml 31ga 8mm.This occurred on 3 separate occasions during use, however, the date/time information is unknown.The following information was provided by the initial reporter: it was reported that needle hub separated with shield.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.10.Device available for eval? yes.D.10 returned to manufacturer on: (b)(6) 2020.H.2 device return to manuf.?: yes.H.2 device eval by manufacturer?: yes.H.6 information updated based on samples received: h.6.Method codes: 10.H.6.Result codes: 170.H.6.Conclusion codes: 23.H.6.Investigation summary: unable to perform complaint lot history check for needle hub separates due to unknown lot number.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, needle hub separates) was captured and addressed customer returned (3) loose 1/2cc syringes.Customer states that the needle hub separated with the shield.All returned syringes were examined and all were returned with the hub-needle/shield assembly separated from the barrel.Samples will be forwarded to manufacturing (holdrege) on (b)(6) 2020 for further review.Unable to perform dhr check for needle hub separates 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.Root cause description: holdrege received photo complaint, batch #928857, unknown lot number.A visual evaluation of photo found (3) syringes with no needle assemblies attached.There did not appear to be any damage to the tip of the barrel, or anywhere on the syringe.There did not appear to be any core pin damage.Process summary: automatic syringe assembly machine, which feeds 0.3ml, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Dhr, l2l dispatches, logbook entries could not be looked at as no lot number was given.Root cause for this defect cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.Rationale: capa# 1630423 has been opened to address this issue.H3 other text : see h.10.
Event or Problem Description
It was reported that the hub separated from device with a bd syringe 0.5ml 31ga 8mm.This occurred on 3 separate occasions during use, however, the date/time information is unknown.The following information was provided by the initial reporter: it was reported that needle hub separated with shield.

• Brand Name: BD SYRINGE 0.5ML 31GA 8MM
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10457012
• Report Number: 1920898-2020-01118
• Device Sequence Number: 2567634
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: Lay User/Patient
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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