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

Catalog Number 328438

Device Problems Material Separation (1562); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: n/a.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 needle of the bd insulin syringe with bd ultra-fine¿ short needle, separated from the hub (twice), during use.Consumer was seen by a doctor for 1 occurrence, and had x-ray¿s completed.They were unable to find the needle in the patient.In the other occurrence the needle separated while in the medication vial.

Manufacturer Narrative

Investigation results: severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle break off during use and the 2nd related complaint for needle separated in vial on lot # 7192513.Dhr review is not required when there is a capa pertaining to the complaint device.Two investigations were carried out.(b)(4) investigation summary: customer returned (3) loose 3/10cc syringe.Customer states that the needle was not on the syringe after his injection and the needle separated and got stuck in the vial when he drew the insulin.All returned syringes were examined and all exhibited a detached cannula.All syringes were examined under the microscope and exhibited little adhesive in the hub.(b)(4) investigation summary: on 30jan2018, (b)(4) received three (3) loose 0.3ml syringes from reported batch# 7192513.Note: catalog/batch combination were noted to not be a valid combination per sap query.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, it was noted that all samples were received with missing/detached cannulas.All samples were visualized under ultraviolet light and found that one (1) sample exhibited scant amounts of adhesive along the inner hub edge, however, no adhesive was noted within the hub core.The other two (2) samples exhibited adhesive within the hub core, however, the adhesive was noted to not appear to be dispersed around the circumference of the hub core inner walls.During manufacturing, adhesive is applied to the hub and the cannula is exercised within the hub to ensure the proper coverage of adhesive on the cannula and within the hub core.This is then cured to harden the adhesive and affix the cannula within the hub.In all instances noted with the samples returned, inadequate dispersion of adhesive within the hub core was noted.When this occurs, there is an increased risk that the cannula may not be permanently affixed within the hub.Probable root cause is likely that inadequate adhesive application during production lead to cannula detachment during use of the device by the end user.Capa (b)(4) was initiated by the (b)(4) plant to address adhesive run-over and its associated root cause(s).As the catalog/batch combination reported with this complaint cannot be verified, determination of manufacturing date relative to implementation activities associated with this capa is unable to be completed at this time.As per manufacturing: ¿that batch number is not found with that catalog number in (b)(4) 24jan2018¿ bd was able to duplicate or confirm the customer¿s indicated failure.The probable root causes for this issue are: 1) incomplete adhesive cure - uv bulb intensity is insufficient, belt speed through the uv oven is too fast (current controls: in-process inspections, preventive maintenance plan & process parameters have been validated) 2) insufficient adhesive - improper cannulation and adhesive application, adhesive runs out of the barrel tip/hub adhesive well (current controls: point inspect machine detects and ejects defective parts, in-process inspections, waste monitoring) 3) syringe re-use - multiple injections with the same syringe can cause too much pressure on the needle (current controls: single use device per ifu) 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 SYRINGES WITH BD ULTRA-FINE¿ SHORT NEEDLE
• Type of Device: INSULIN SYRINGE WITH 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: 7182516
• MDR Text Key: 96983223
• Report Number: 1920898-2017-00423
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328438
• Device Lot Number: 7192513
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2007
• 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): Required Intervention