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

Catalog Number 928857

Device Problem Volume Accuracy Problem (1675)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation: summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 8022776.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for ink rings.There was one (1) notification [200737777] noted for missing zero line.

Event Description

It was reported with the use of the bd insulin syringe with bd ultra-fine¿ needle there was an issue with scale print is smudged.

Manufacturer Narrative

Investigation summary: customer returned (4) 1/2cc, 8mm, 31g walgreens syringes in an open poly bag from lot # 8022776.Severity ranking is s1.A complaint history check was performed and this is the 1st related complaint for scale marking defective on lot # 8022776.A review of the device history record was completed for batch# 8022776.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification that did not pertain to the complaint.There was one (1) notification for ink rings.There was one (1) notification for missing zero line.Investigation conclusion: all returned syringes were examined and all exhibited incomplete scale markings printed on the barrel.Samples were forwarded to manufacturing (holdrege) on 04jan2019 for further review.On 04jan2019, holdrege received four (4) 0.5ml, 8mm, 31g walgreen's syringes in an opened polybag from batch# 8022776.All samples were decontaminated per hstr-17 and hqa-68 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.All returned samples exhibited scratched/missing print with spots of accumulated print ink material along the surface of the barrel.Root cause description: probable root cause is most likely to be a dirty dr blade on the printers during printing of the scale markings on the syringes.When this occurs, portions of the print may become scratched or completely removed from the barrel surface, as is noted within the returned samples.Rationale: capa (b)(4) was initiated to address such issues 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.

Event Description

It was reported with the use of four bd insulin syringe with bd ultra-fine¿ needle there was an issue with scale print being smudged.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8197902
• MDR Text Key: 131494746
• Report Number: 1920898-2018-00956
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 928857
• Device Lot Number: 8022776
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other