MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP; CONVENTIONAL SYRINGE

Catalog Number 309657

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)

Patient Problem Blurred Vision (2137)

Event Date 01/16/2018

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 that before use, a bd luer-lok¿ disposable syringe with bd luer-lok¿ tip was found with volumetric inaccuracy as ¿the graduated lines on the syringe were blurry, illegible and inaccurate.¿ there was no report of injury or medical intervention reported.

Manufacturer Narrative

Investigation results: a large bag of approximately 100 assembled sealed packaged 3ml syringes confirmed to be from batch #7267924 (p/n 309657) was received and visually evaluated.All of the samples had smudged/illegible print condition.The smudged print was found at the bd logo and the 2 ml symbol on all syringes with those markings completely illegible.The smudging was observed progressively worse on some of the other samples extending to the scale markings and other numerical markings, rendering them illegible as well.Dhr review for batch 7267924 (p/n 309657): manufacturing dates: 10/10/2017 to 10/11/2017.Batch quantity was 772,000.Printing records were reviewed as part of this dhr review.Machine logs indicate printer issues occurred.Quality notification for missing print was recorded during the manufacture of this batch.Product was requalified per applicable aql and manifold system cleaning was performed to address the issues before production resumed.All visual inspections were performed as per requirement.Batch 7267924 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Potential root cause: printer issues were recorded during production with a related quality notification.The smeared/illegible print observed is likely a result of ink flow problems due to an ink manifold issue.Based on the sample evaluation bd canaan was able to confirm the customer's indicated failure.Capa not required based on severity and occurrence level defined for this complaint.

• Brand Name: BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7311269
• MDR Text Key: 101487112
• Report Number: 1213809-2018-00081
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 309657
• Device Lot Number: 7267924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Date Manufacturer Received: 02/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other