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

Catalog Number 324912

Device Problems Mechanical Problem (1384); Suction Failure (4039)

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

Event Date 03/11/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.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.Device manufacture date: unknown.

Event Description

It was reported that during use of the bd¿ insulin syringe with the bd ultra-fine¿ needle the syringe would not draw the medication.On another syringe after pulling the plunger back it fell back into the barrel.Material no.324912 batch no.Unknown (provided: 896458).The following information was provided by the initial reporter: verbatim: consumer stated on (b)(6) 2019 one syringe would not draw her insulin and the second syringe when she pulled on the plunger rod it fell back in the barrel.She used the 3rd syringe that worked.Samples are available.Lot# 896458 ; item # 324912; exp-04/30/2023.Offer to send a replacement voucher.

Manufacturer Narrative

H.6.Investigation summary: customer returned (2) loose 1cc, 6mm syringes.Customer states that one syringe would not draw her insulin and the second syringe when she pulled on the plunger rod it fell back in the barrel.Both syringes were examined and both syringes were not able to draw.One syringe exhibited adhesive runoff onto the barrel.The remaining syringe exhibited material in the lumen of the cannula blocking the fluid path.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.Both of these issues could cause the syringe to not draw properly.Capa 226773 has been opened to address the adhesive runoff issue for 1ml syringes.Unable to perform dhr check for unable to operate (not drawing) and plunger rod difficult to move due to unknown lot number.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (adhesive runoff and clogged needle).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.Root cause: probable root cause determined to be misalignment during application of adhesive on the needle lines.When this occurs, adhesive runover onto the hub or possible the cannula may occur.Additionally, adhesive may be inaccurately applied to the rubberized pull wheel on the line, which can additionally transfer adhesive to the cannula during routine use.Capa 226773 has been opened to address this issue for 1ml syringes.Probable root cause for the silicone clog is from excess silicone applied at the metros from an out of adjustment silicone gun.

Event Description

It was reported that during use of the bd¿ insulin syringe with the bd ultra-fine¿ needle the syringe would not draw the medication.On another syringe after pulling the plunger back it fell back into the barrel.Material no.324912.Batch no.Unknown (provided: 896458).The following information was provided by the initial reporter: verbatim: consumer stated on (b)(6)2019 one syringe would not draw her insulin and the second syringe when she pulled on the plunger rod it fell back in the barrel.She used the 3rd syringe that worked.Samples are available.Lot# 896458 ; item # 324912; exp-04/30/2023.Offer to send a replacement voucher.

• Brand Name: BD INSULIN SYRINGE WITH THE 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: 8480666
• MDR Text Key: 140919632
• Report Number: 1920898-2019-00317
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other