MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 8MM 10BAG 500 WAL; INSULIN SYRINGE

Catalog Number	328511
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that two syringe 0.3ml 30ga 8mm 10bag 500 wal experienced difficult plunger movement.The following information was provided by the initial reporter: material no.328511, batch no.Unknown.Verbatim: relion syringe 3/10ml cc 30g 8mm plunger stopper seems too large.Its tight and hard to move the plunger rod.Not sure what box or bag it came from.Found 2 syringes unknown lot # unknown occd date.
Additional Manufacturer Narrative
Investigation: unable to perform dhr review for stopper damaged/disfigured and plunger rod difficult to move due to unknown lot number.Customer returned (1) loose 0.3ml, 30g x 8mm relion insulin syringe.Consumer reported plunger stopper seems too large; it¿s tight and hard to move the plunger rod.The returned sample was examined and was observed to have a damaged stopper.This condition is referred to as a rolled stopper which can occur during the assembly process, when the plunger rod is being assembled in the barrel and there is inadequate (not enough) lube present in the barrel id (inner diameter) and or the stopper itself does not have enough lube on it.As a result, the stopper does not move freely in the barrel and can become stuck and deformed.There is also the possibility that the stopper starts out being misaligned on the end of the plunger rod and then gets rolled as it is being inserted inside the barrel.Rolled stoppers can also be caused by partially peeling off the stopper before insertion into the syringe barrel.As per supplier, improper stacking of rubber sheets in autoclave cart, causing pinching/deformity.Capa 122939 has been opened to address this issue.
Event or Problem Description
It was reported that two syringe 0.3ml 30ga 8mm 10bag 500 wal experienced difficult plunger movement.The following information was provided by the initial reporter: material no.328511 batch no.Unknown.Verbatim: relion syringe 3/10ml cc 30g 8mm plunger stopper seems too large.Its tight and hard to move the plunger rod.Not sure what box or bag it came from.Found 2 syringes unknown lot # unknown occd date.

• Brand Name: SYRINGE 0.3ML 30GA 8MM 10BAG 500 WAL
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8555287
• Report Number: 1920898-2019-00391
• Device Sequence Number: 1968312
• Product Code: FMF
• UDI-Device Identifier: 00681131311724
• UDI-Public: 00681131311724
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 328511
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/17/2019
• 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