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

Catalog Number 328325

Device Problems Break (1069); Out-Of-Box Failure (2311)

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

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (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 ultra-fine insulin syringe and needle there was an issue with the barrel being broken.It was stated ¿after opening a new syringe pack, at the beginning of aspiration the insulin, the customer realized the syringe did not pull the medicine.Only air was coming and when she looked in the syringe she noticed the cylinder was cracked.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Two investigations were carried out.First investigation summary: customer returned (10) 1/2cc, 8mm, 30g syringes in an open poly bag from lot # 7100858.Customer states that the syringe did not pull the medicine and the cylinder was cracked.All returned syringes were examined and one sample exhibited a crack in the barrel ranging from the 3-15 unit markings.This could cause the syringe to not draw properly.All remaining syringes were tested and all were able to draw and expel properly without any observed defects.Samples were forwarded to manufacturing (holdrege) on 25may2018 for further review.Second investigation summary: on 30may2018, holdrege received ten (10) 0.5ml, 8mm, 30g syringes in opened polybag from batch # 7100858.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 franklin lakes were noted.The damaged sample was inspected for any damage to the hub assembly (hub, cannula, shield) and none was noted.Probable root cause is likely to be a jam on the prep dial during assembly, resulting in the cracked barrel and accounting for no damage to the hub assembly.A review of the device history record was completed for batch# 7100858.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200693429, 200691866] noted that did not pertain to the complaint.There was one (1) notification [200694301] noted for cracked hubs.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for clog and the 1st related complaint for broken barrel on lot # 7100858.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (cracked barrel).Based on the above, no capa is required at this time.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 AND 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: 7512744
• MDR Text Key: 108497571
• Report Number: 1920898-2018-00352
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2022
• Device Catalogue Number: 328325
• Device Lot Number: 7100858
• Date Manufacturer Received: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other