MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Catalog Number 328431

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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.

Event Description

It was reported that the plunger on an insulin syringe with bd ultra-fine¿ needle was difficult to press and during injection the stopper ¿turns sideways¿ possibly affecting the dosage.There was no report of injury or medical interventions.

Manufacturer Narrative

Investigation summary: customer returned (14) 3/10cc, 12.7mm, 30g syringes (4 in an open poly bag, 10 in a sealed poly bag) from lot # 6221866.Customer states that the plunger rod is difficult to move and the stopper turns sideways while injecting.All returned syringes were examined and one sample exhibited a deformed stopper in the barrel that could cause the plunger rod to be difficult to move.The noted sample exhibiting the deformation of the stopper was cycle tested without notable findings at this time.Additionally, the stopper was disassembled from the syringe barrel and was noted to retain its deformed configuration.A review of the device history record was completed for batch # 6221866 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.Probable root cause could be a supplier related issue or a misalignment during assembly of the plunger rod/stopper into the syringe barrel.(b)(4) was initiated by the holdrege plant to address deformed/damaged stoppers and their associated root cause(s).Batch# 6221866 was manufactured prior to initiation of this capa.No additional actions deemed necessary at this time.

Manufacturer Narrative

Investigation summary: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch # 6221866 all inspections were performed per the applicable operations qc specifications.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger rod difficult to move and the 2nd related complaint for stopper damaged/deformed on lot # 6221866.Assembled syringes ¿ there was one (1) batch of material# 700007540 (syringe 0.3ml asm 30g1/2in tw sm700179sc) that went into the packaged batch# 6221866.Batch#: 6258712.Date(s) of manufacture: 25sep2016 to 26sep2016.Machine(s) produced on: jw, jx, jz.There were zero (0) notifications noted that pertained to the complaint.Based on the samples / photo(s) received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.If samples are received in the future the complaint will be reopened for further investigation.

• Brand Name: INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7508578
• MDR Text Key: 108153069
• Report Number: 1920898-2018-00324
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328431
• Device Lot Number: 6221866
• Date Manufacturer Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other