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

Catalog Number 328418

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd insulin syringe with the bd ultra-fine¿ needle detached from the syringe remaining in the vial and then leaked during use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned one loose 1cc syringe.The returned syringe was examined and exhibited a detached cannula.The loose cannula was received inside the barrel.The barrel was examined under the microscope and exhibited adhesive runoff onto the hub with little adhesive inside the hub.The loose cannula was removed from the barrel and exhibited adhesive on the cannula shaft.The sample was not able to be tested for air bubbles or leakage as the cannula was detached from the syringe.Sample will be forwarded to manufacturing (b)(4) on 26jan2018 for further review.As per manufacturing, a review of the device history record was completed for batch# 7241568.All inspections were performed per the applicable operations qc specifications.There were three notifications noted for insufficient adhesive.There were six notifications noted that did not pertain to the complaint.Investigation conclusion: based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (adhesive runoff onto hub).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (air bubbles and leakage).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 (b)(4) was initiated by the (b)(4) plant to address 1ml product complaints.On 30jan2018,(b)(4) received one loose 1ml syringe from reported batch# 7241568.All samples were decontaminated per (b)(4) prior to being evaluated.Upon evaluation by (b)(4), it was noted that the sample was received with the cannula detached form the remainder of the syringe and was located within the shield.The sample was visualized under ultraviolet light and noted adhesive along the side of the barrel tip/well and scant traces of adhesive down the barrel core.Additionally, the cannula was also visualized under ultraviolet light and noted small traces of adhesive along the exterior wall of the cannula.Probable root cause likely to be a misalignment of the adhesive nozzle during production of this batch.When this occurs, adhesive can generally be found along the side of the barrel tip, leaving little to no adhesive down the barrel core where affixation of the cannula occurs.This can increase the chances of cannula separation from the remainder of the syringe, either during transport or initial aspiration of insulin.Capa (b)(4) was initiated by the (b)(4) plant to address 1ml product complaints, including cannula separates, and their associated root cause(s).Batch# 7241568 was manufactured prior to implementation of corrective/preventive actions.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE
• 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: 7173250
• MDR Text Key: 96823040
• Report Number: 1920898-2017-00431
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328418
• Device Lot Number: 7241568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2017
• 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