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

Catalog Number 326103

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the plunger of a bd ultra-fine¿ insulin syringe was difficult to push.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned (203) 3/10cc, 12.7mm, 29g syringes (23 in open poly bags, 180 in sealed poly bags) with the shelf cartons from lot # 6326857.Customer states that the rubber in the syringe is too tight to push forward and needs to push very hard during procedure.All samples in the open poly bags were examined and 21 out of 23 samples exhibited a deformed stopper.Also, 30 out of 180 samples in the sealed poly bags were examined and 19 out of 30 samples exhibited a deformed stopper in the barrel.The deformed stopper could result in the plunger rod being difficult to move.Samples will be forwarded to manufacturing (holdrege) on 27jul2018 for further review.On 01aug2018, holdrege received two hundred and three (203) 0.3ml, 12.7mm, 29 g syringes (23 in opened polybags and 180 in sealed polybags) with shelf cartons from batch # 6326857.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.All samples were visually inspected and a total of one hundred and twenty six (126) of the returned samples exhibited a deformed stopper, as visualized within the fully assembled syringe.Samples from the open polybags were cycle tested with very little increase in force necessary to complete this testing.Additionally, selected samples were disassembled and noted that the stopper retained the deformed configuration, as noted within the assembled syringe.Potential root causes include, but are not limited to: insufficient lubricant within the syringe barrel during assembly; a supplier related molding/dimension defect; and/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# 6326857 was manufactured prior to initiation of this capa.A review of the device history record was completed for batch# 6326857.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for stopper damaged and the 1st related complaint for plunger difficult to move on lot # 6326857.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.

Event Description

It was reported that the plunger of a bd ultra-fine¿ insulin syringe was difficult to push.There was no report of exposure, injury or medical intervention.

• 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: 7635182
• MDR Text Key: 112470881
• Report Number: 1920898-2018-00442
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 326103
• Device Lot Number: 6326857
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other