MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE INSULIN SYRINGE; PISTON SYRINGE

Model Number	928856
Medical Device Problem Codes	Leak/Splash (1354); Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.Unknown, (b)(6) usa has been used as a placeholder based on the reported phone area code.(b)(4).Investigation summary: no samples 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# 9241004.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Occurrence: a complaint history check was performed and this is the 1st related complaint for plunger cap damaged/hole, shield damaged/hole, plunger rod unable to move, needle bent and needle dull on lot # 9241004.A review of risk management (b)(4) indicates that the potential risk of this specific reported incident (syringe, plunger cap damaged/hole, shield damaged/hole, plunger rod unable to move, needle bent and needle dull) was captured and addressed appropriately.Investigation conclusion: 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 above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that 2 bd safetyglide¿ insulin syringes had holes in their plunger caps and needle shields, and 4 syringes had difficult plunger rod movement.All defects were noticed during use in lot# 9241004.The following information was provided by the initial reporter: "consumer reported that there are holes in the plunger cap and needle shields of two syringes.Plunger rod will not move, asked consumer if the rod was difficult to move and he said it will not move.Needle was bent when shield was removed.Needles dull.Issues involve 4 syringes.".

• Brand Name: BD SAFETYGLIDE INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10269440
• Report Number: 1920898-2020-00838
• Device Sequence Number: 14358543
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• 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
• Report Date (Section B): 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2024
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: 9241004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/14/2020
• 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