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

Catalog Number	309644
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
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 10 units of the customers bd luer-lok¿ syringe with bd precisionglide¿ needle were cracked and leak.It is unspecified when the event occurred.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation results: one loose 10ml luer lok syringe with no packaging was received by bd (b)(4) for investigation.Customer reported lot number #7300578, catalog # 309644.Based on visual examination of the returned sample, cracked barrel was observed and the crack was almost along the entire syringe barrel.Product defect confirmed based on sample evaluation performed.Dhr review for batch 7300578 (p/n 309644): manufacturing dates: 11/02/2017 to 11/03/2017.Batch quantity was (b)(4).Printing and 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 7300578 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Root cause not required based on severity and occurrence level defined for this complaint.Based on the severity and occurrence a capa is not necessary.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 BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7346284
• Report Number: 1213809-2018-00162
• Device Sequence Number: 13649332
• Product Code: FMF
• UDI-Device Identifier: 00382903096442
• UDI-Public: 00382903096442
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 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: 10/31/2022
• Device Catalogue Number: 309644
• Device Lot Number: 7300578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/05/2018
• 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