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

Catalog Number 326631

Device Problems Out-Of-Box Failure (2311); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that before use a bd ultra-fine¿ insulin syringe was found with ¿the thumb press was deformed.¿ there was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation results: two investigations were carried out.First investigation summary: customer returned (1) loose 3/10cc syringe filled with approximately 5 units of a clear liquid.Customer states that the thumb press was deformed.The returned syringe was examined and no defects were observed on the thumb press.However, the sample exhibited a deformed stopper.Sample was forwarded to manufacturing (holdrege) on (b)(6) 2018 for further review.Second investigation summary: on (b)(6) 2018, holdrege received one (1) loose 0.3ml syringe filled with ~5 units of unknown clear liquid from an unknown batch number.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 (b)(4) were noted.The sample was cycle tested and noted sufficient lubrication within the syringe at the time of testing.Due to the unknown fluid within the syringe, the device was not disassembled to inspect the stopper itself.Probable root cause is likely to be a supplier related issue, however, this is unable to be verified at this time.Capa (b)(4) was initiated by the holdrege plant to address deformed/damaged stoppers and their associated root cause(s).As the batch is unknown for the received sample, we are unable to verify the manufacturing day and its temporal relevance to capa (b)(4).Unable to perform dhr check due to unknown lot number.Severity: s_1__; occurrence: unable to perform complaint lot history 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 (deformed stopper).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 ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7366938
• MDR Text Key: 103540006
• Report Number: 1920898-2018-00170
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326631
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other