MAUDE Adverse Event Report: BECTON DICKINSON BD LUER-LOK¿ SYRINGE WITH NEEDLE; HYPODERMIC SYRINGE AND NEEDLE

Catalog Number	303020
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.Device manufacture date: unknown.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 the bd luer-lok¿ syringe with needle had a crack in the barrel.Found during use.No serious injury or medical intervention noted.
Additional Manufacturer Narrative
Correction information on "date received by manufacturer:" the following field has been updated.Date received by manufacturer: 11/20/2017.
Additional Manufacturer Narrative
Investigation results: one 3ml syringe with needle and open convenience pack was received by bd canaan and confirmed to be from batch #7220010 (p/n 303020).A crack was observed between approximately ½ ml to the 2ml markings.Cracked barrel is a rejectable condition as per product specification.A device history record review for 3ml syringe batch 7130877 (p/n 304740): bulk non-sterile as well as for finished product 3ml syringe with 22gx1 needle lot # 7220010 (p/n 303020) showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the evaluation performed, bd was able to confirm the customer¿s indicated failure.Root cause and capa not required based on severity and occurrence level defined for this complaint.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 LUER-LOK¿ SYRINGE WITH NEEDLE
• Common Device Name: HYPODERMIC SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7115865
• Report Number: 2243072-2017-00397
• Device Sequence Number: 11136867
• Product Code: FMF
• UDI-Device Identifier: 30382903030201
• UDI-Public: 30382903030201
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2018

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: Pharmacist
• Device Catalogue Number: 303020
• Device Lot Number: 7220010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 11/20/2017; 11/20/2017
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/31/2018; 05/01/2018
• 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