MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ RELION® INSULIN SYRINGE W/NEEDLE

Catalog Number	328510
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2018
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 stopper on a bd¿ relion® insulin syringe was deformed (described as ¿crooked¿).The syringe was not used and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
Investigation summary: customer returned one 3/10cc, 12.7mm, 29g relion syringe in an open poly bag from lot # 7044916.The returned syringe was examined and exhibited a deformed stopper in the barrel.As per manufacturing, a review of the device history record was completed for batch# 7044916.All inspections and challenges were performed per the applicable operations qc specifications.There was one notification noted that did not pertain to the complaint.Investigation conclusion: based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Possible root causes for a damaged stopper include: 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.

• Brand Name: BD¿ RELION® INSULIN SYRINGE W/NEEDLE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7350112
• Report Number: 1920898-2018-00134
• Device Sequence Number: 13649342
• Product Code: FMF
• UDI-Device Identifier: 00681131311663
• UDI-Public: 00681131311663
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2018

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: 328510
• Device Lot Number: 7044916
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/19/2018
• Supplement Report FDA Received Date: 04/24/2018
• 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