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

Catalog Number	309578
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided.Medical device expiration date: unknown.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 normal saline leaked from a small crack in the barrel of a bd luer-lok¿ syringe with precisionglide¿ detachable needle during use.There was no report of exposure, injury or medical interventions.
Additional Manufacturer Narrative
Lot # provided: 3121188.Medical device expiration date: unknown.Device manufacture date: 05/30/2013.A single 3ml syringe was received in an opened package confirmed to be from batch #3121188 (p/n 309578).The syringe was filled with 2.5 ml of unidentified clear liquid, therefore the sample was evaluated through the sample bag only.A crack in the barrel was visible extending from the luer collar to approximately 1 ½ ml marking outside the scale.Dhr review for batch 3121188 (p/n 309578): manufacturing dates: 05/28/2013 to 05/29/2013.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 3121188 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment based on the sample evaluation: confirmed: bd canaan 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 W/PRECISIONGLIDE¿ DETACHABLE 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: 7263595
• Report Number: 1213809-2018-00035
• Device Sequence Number: 1826627
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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 Catalogue Number: 309578
• Device Lot Number: 3121188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 04/02/2018
• 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