MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP STERILE SYRINGE

Catalog Number	309656
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that medication leaked from a crack in a bd¿ slip tip sterile syringe.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: additionally, a 3ml opened package syringe was received at bd (b)(4), confirmed to be from batch # 7002606, (p/n 309656).The sample was visually evaluated.The syringe had a linear crack extending from the 1ml to the 1 1/2 grad line along the print area.Based on the sample evaluation, product defect is confirmed.Root cause is still undetermined.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
Investigation summary: dhr review for batch 7002606: manufacturing dates: 01/28/2017 to 01/30/2017.Batch quantity was 768,000.Batch assembly 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 7002606 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Sample evaluation: two photos were received by bd (b)(4) and evaluated.The photos depict two sides of the top web of a 3ml package confirmed to be from batch #7002606.No syringe, including the reported defect, could be seen in the photos.Therefore the defect could not be confirmed and the root cause is undetermined.Investigation conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD¿ SLIP TIP STERILE SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7116883
• Report Number: 1213809-2017-00347
• Device Sequence Number: 1358735
• Product Code: FMF
• UDI-Device Identifier: 30382903096566
• UDI-Public: 30382903096566
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2018

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: 12/31/2021
• Device Catalogue Number: 309656
• Device Lot Number: 7002606
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 11/21/2017; 11/21/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 02/09/2018; 03/28/2018
• 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