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

Catalog Number 328438

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle had a stopper that was "slanted at a 45 degree angle making it difficult to move the plunger".No serious injury or medical intervention was reported.

Event Description

It was reported that bd insulin syringe with bd ultra-fine¿ needle had a stopper that was "slanted at a 45 degree angle making it difficult to move the plunger".No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: customer returned (1) 3/10cc, 8mm, 31g syringe in an open poly bag from lot # 7306560.Customer states that the stopper is slanted at a 45 degree angle making it difficult to move the plunger rod.The returned syringe was examined and exhibited a deformed stopper in the barrel.This issue could cause the plunger rod to be difficult to move.Sample was forwarded to manufacturing (holdrege) on 05oct2018 for further review.On 09oct2018, holdrege received one (1) 0.3ml, 8mm, 31g syringe in opened polybag from batch # 7306560.Samples are 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.The returned device was evaluated by attempting to perform cycle testing (exercising the plunger rod/stopper within the syringe barrel, simulating usage of the device).This test was unable to be performed due to the gross resistance noted while attempting to move the plunger rod.The plunger rod/stopper were eventually disassembled from the remainder of the device.Both the stopper and the interior of the barrel were noted to be dry or exhibiting scant traces of the usual silicone lubricant.Probable root cause determined to be insufficient silicone within the syringe barrel, resulting potentially in a dry barrel.When this type of even occurs, and successful assembly of the plunger rod/stopper into the barrel occurs, the stopper can become deformed due to the additional drag as it is pushed down the barrel.Generally, the resulting device is rendered inoperable by the end user due to the inability to move the plunger rod.A review of the device history record was completed for batch # 7306560 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200726801] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for stopper damaged/disfigured and plunger rod difficult to move on lot # 7306560.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.(b)(4) has been opened to address this issue.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.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7889605
• MDR Text Key: 120973017
• Report Number: 1920898-2018-00722
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• 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
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 328438
• Device Lot Number: 7306560
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other