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

Catalog Number	305062
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that scale markings on a bd plastipak¿ syringe with luer-lok¿ tip were found faded making them illegible.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Six 5ml packaged syringes and four photos received at bd canaan, confirmed to be from batch # 8011856.Sample was visually evaluated.The syringes were found to have missing print between the 2ml and the 5ml gradlines.Missing print run vertical or the long direction of the barrel.Samples are considered rejectable per product specification.Based on the evaluation performed, product defect is confirmed.Dhr review for batch 8011856: manufacturing dates: 01/23/2018 to 01/25/2018.Batch quantity was (b)(4).Printing records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8011856 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Confirmed: bd was able to confirm the customer¿s indicated failure.

• Brand Name: BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7397006
• Report Number: 1213809-2018-00172
• Device Sequence Number: 10811678
• Product Code: FMF
• UDI-Device Identifier: 00382903050628
• UDI-Public: 00382903050628
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2018

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
• Operator of Device: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 305062
• Device Lot Number: 8011856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other