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

Model Number	328506
Medical Device Problem Codes	Leak/Splash (1354); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2020
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: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the packaging was cut and sterility was compromised as well as plungers separated with a relion® insulin syringe.The following information was provided by the initial reporter: it was reported that syringe polybags were cut.Also reported plunger caps laying in bags and some syringe plungers were laying in the bag or even missing.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned as of 8 may 2020 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# 9231251.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the packaging was cut and sterility was compromised as well as plungers separated with a relion® insulin syringe.The following information was provided by the initial reporter: it was reported that syringe polybags were cut.Also reported plunger caps laying in bags and some syringe plungers were laying in the bag or even missing.
Event or Problem Description
It was reported that the packaging was cut and sterility was compromised as well as plungers separated with a relion® insulin syringe.The following information was provided by the initial reporter: it was reported that syringe polybags were cut.Also reported plunger caps laying in bags and some syringe plungers were laying in the bag or even missing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/13/2020.H.6.Investigation: customer returned one (1) sealed polybag for 31gx8mm, 1ml insulin syringes from lot 9231251.Consumer reported: the syringe bags in this box were cut open looks like with a razor, the syringes plunger caps laying in the bags, and the syringe plungers out of syringe laying in the bag or even missing.The returned polybag was examined and the following was observed: - the polybag was damaged - a broken plunger cap was loose inside the polybag - a broken plunger rod was loose inside the polybag - 10 syringes with no apparent defects a review of the device history record was completed for batch# 9231251.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.- confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (damaged polybag, broken plunger cap, broken plunger rod) - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (missing plunger rod) process summary: a dial transfers the correct number of syringes to a tube where they drop by gravity through the tube coming to rest on top of the polybag sealing jaws.The polybag is formed by web that is wrapped around a metal tube where the sides of the web overlap and are sealed to form the vertical seal.Sealing jaws form the polybag bottom, as well as the top of the previous polybag.Between the sealing jaws is a knife that severs the bag from the roll.The bags are then conveyed to be hand packed into erected cartons.The cartons are then closed and placed on the outfeed conveyor to be loaded into cases and palletized.There were no quality notifications or maintenance dispatches during the production of this batch that pertained to this defect.The dhr was reviewed and nothing pertaining to the defect was found.A root cause cannot be determined.H3 other text : see h.10.

• Brand Name: RELION INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10014866
• Report Number: 1920898-2020-00445
• Device Sequence Number: 2553697
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 06/11/2020

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: 328506
• Device Catalogue Number: 328506
• Device Lot Number: 9231251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 04/10/2020
• Supplement Date Received by Manufacturer: 04/10/2020; 04/10/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 05/08/2020; 06/11/2020
• 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