MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PLASTIC PACK¿ / BD LORD'S¿ INSULIN SYRINGE WITH NEEDLE

Catalog Number 326638

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: n/a.Device manufacture date: unknown.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 with the use of the bd plastic pack¿ / bd lord's¿ insulin syringe with needle there was an issue with malfunction of the device.The customer stated ¿the stopper was deformed.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: customer returned one loose 3/10cc, 8mm syringe.Customer states that the stopper was deformed.The returned syringe was examined and exhibited a deformed stopper in the barrel.Unable to perform dhr check due to unknown lot number.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.Capa 122939 has been opened to address this issue.The sample was cycle tested and a slight increase in the force required to complete this testing was noted, though negligible.The sample was additionally disassembled and the stopper was noted to retain its deformed configuration.Potential root causes include misalignment during assembly/manufacturing or a supplier related defect.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.

• Brand Name: BD PLASTIC PACK¿ / BD LORD'S¿ INSULIN SYRINGE WITH NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7452148
• MDR Text Key: 106340037
• Report Number: 1920898-2018-00292
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326638
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other