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

Catalog Number 324916

Device Problems Bent (1059); Device Markings/Labelling Problem (2911)

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

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).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 measure markings on a bd ultra-fine¿ insulin syringe were "blurry and bent".There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: two investigations were carried out.First investigation summary: customer returned (11) 3/10cc, 6mm, 31g syringes in open poly bags from lot # 5348646.Customer states that the scale marking is blurry and slightly bent.All returned syringes were examined and all exhibited smudged and blurry scale markings.Samples will be forwarded to manufacturing (holdrege) on 27apr2018 for further review.Second investigation summary: on 01may2018, holdrege received eleven (11) 0.3ml, 6mm, 31g syringes in opened polybags from batch # 5348646.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.Smudging of the ink, such as is exhibited by the returned samples, is typically due to a swelling of the pad on the printer during manufacturing.When this occurs, the pad may not neatly "kiss" the surface of the barrel and can leave smudges or ink in the incorrect pattern to the scale print.All samples were additionally visualized under 4x magnification, as was the attached photo from bd franklin lakes, and all exhibit a slight separation between the scale print line and the smudge.As this could appear as an additional scale marking and lead to dosing issues for the consumer, this phenomenon, if noted during inspection while the batch was being manufactured, would be classified as a defect.Capa 162566 was initiated by the holdrege plant to address print related defects and their associated root cause(s).Batch# 5348646 was manufactured prior to initiation of this capa.No additional actions at this time.A review of the device history record was completed for batch # 5348646 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for scale marking distorted on lot # 5348646.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7477609
• MDR Text Key: 107461220
• Report Number: 1920898-2018-00279
• Device Sequence Number: 1
• Product Code: FMF
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 324916
• Device Lot Number: 5348646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other