MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE

Model Number	328519
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.(b)(4).Level b investigation: complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for difficult/unable to operate (plunger movement) on lot # 9231247.A review of risk management (b)(4) revision 13 indicates that the potential risk of this specific reported incident (syringe, difficult/unable to operate (plunger movement) was captured and addressed.Investigation summary: customer returned (81) 31gx6mm, 1ml insulin syringes from lot 923124 (1 used syringe, 80 syringes in unused/sealed polybags).Consumer reported that the plunger moves on its own before placed in vial.The 1 syringe returned after use was examined, and it was observed that a small amount of insulin was inside the barrel, and that the cannula was clogged; the plunger rod was not able to move properly on this syringe.A wire test was performed on this syringe, and the wire was able to pass through the cannula; however, the material causing the clog was not retrieved, and therefore could not be identified.30 out of the 80 syringes returned unused were examined, then tested for plunger rod movement: all 30 syringes exhibited plunger rods that were able to move properly.No evidence of manufacturing defect was observed on these 30 tested samples.The clog would be the cause for difficulties observed when moving the plunger rod.A review of the device history record was completed for batch# 9231247.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Investigation conclusion: 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 (clog).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: the root cause for this issue (clogged cannula) could not be determined because the material causing the clog was not retrieved or identified.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion plunger was moving on it's own.This was discovered during use.The following information was provided by the initial reporter: material no:328519, batch no: 9231247.It was reported that the plunger moves on its own before placed in vial.

• Brand Name: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10491967
• Report Number: 1920898-2020-01162
• Device Sequence Number: 11526820
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2020

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: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 9231247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/03/2020
• 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