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

Catalog Number 328466

Device Problems Break (1069); Difficult to Remove (1528); Material Separation (1562)

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

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd insulin syringe with the bd ultra-fine¿ needle there was an issue with plunger rod broken, needle hub separating and shield difficult to remove.There was no report of injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: yes.Investigation summary: customer returned ( 3 ) loose 1/2cc syringes.Customer reported shield difficult to remove, needle and hub found inside cap and broken plunger rod.The returned syringes were examined and 2 syringes exhibited a broken plunger.No damage could be observed on the remaining returned syringe (no needle hub separation observed on either of the returned syringes).The 3 returned syringes were tested to determine the shield removal forces and the following was observed (specs: shield removal force for 3/10 cc after sterilization is 0.85 to 5.95lbs): sample number: shield removal force (lbs): sample 1: 3.95.Sample 2: 1.63.Sample 3: 2.99.A review of the device history record was completed for batch# 7240944.All inspections and challenges were performed per the applicable operations qc specifications.There were five (5) notifications [200715117, 200715768, 200715109, 200715108, 200713390] 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 shield difficult to remove/detach, needle hub separates and plunger rod broken on lot # 7240944.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure - broken plunger.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure - shield difficult to remove.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure - needle hub separates.Sample was forwarded to manufacturing (holdrege) on 31 august 2018 for further review.On 11sep2018, holdrege received three (3) loose 0.5ml, 12.7mm syringes from reported batch # 7240944.All 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.For the two (2) samples which exhibited a broken plunger rod, probable root cause is likely to be a jam on the metro, post assembly of the plunger rod/stopper into the syringe barrel.As there is no damage associated with the plunger cap or any of the other remaining components, damage associated with downstream equipment (i.E.- form fill & seal, etc) is unlikely.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.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported with the use of the bd insulin syringe with the bd ultra-fine¿ needle there was an issue with plunger rod broken, needle hub separating and shield difficult to remove.There was no report of injury or medical intervention.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7790557
• MDR Text Key: 117446502
• Report Number: 1920898-2018-00644
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: 00382908466035
• 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: 09/10/2018

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: 328466
• Device Lot Number: 7240944
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 08/01/2018
• Supplement Dates FDA Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other