MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE

Catalog Number 324918

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd ultra-fine¿ insulin syringe was difficult to use.The customer also stated that the plunger looked crooked/bent making it difficult to administer the correct dose.Found during use.No serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: customer returned two 1cc, 6mm, 31g syringes in an open poly bag from lot # 5159705.Customer states that the plunger was difficult to move and the rubber was crooked.Both returned syringes were examined and both exhibited a deformed stopper in the barrel.This could cause the plunger rod to be difficult to move.As per manufacturing, a review of the device history record was completed for batch# 5159705.All inspections were performed per the applicable operations qc specifications.There were zero (0) defects or notifications noted for any defects during the production of these batches.Upon evaluation by (b)(6), similar findings to those documented during initial investigation performed at bd franklin lakes.Both samples were evaluated through cycle testing, which noted an increased resistance to movement of the plunger rod.All samples were then disassembled and their stoppers were noted to retain their deformed configuration.Probable root cause likely to be missing or insufficient silicone lubrication within the syringe barrel prior to assembly of the plunger rod/stopper within the syringe barrel.When this occurs, there is an increased chance that the stopper would drag along any or all edges as it was exercised within the barrel.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 (deformed stopper and plunger difficult to move).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 was initiated by the holdrege plant to address deformed/damaged stoppers and their associated root cause(s).Batch# 5159705 was manufactured prior to initiation of this capa.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7280992
• MDR Text Key: 100558289
• Report Number: 1920898-2018-00051
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 324918
• Device Lot Number: 5159705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR