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 Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
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: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that with use, five bd luer-lok¿ syringe with precisionglide¿ detachable needles were found broken as a crack was found in the barrel.There was no report of exposure, injury or medical intervention needed.
Additional Manufacturer Narrative
Investigation summary: sample evaluation: one packaged and four opened packaged 3ml syringes received at bd canaan, confirmed to be from batch # 7212714 (p/n 309578).The samples were visually evaluated.All samples have damage at about 1 1/4 ml.Damage goes through barrel side wall and appears to cause crack in the wall of the barrels.Dhr review for batch 7212714 (p/n 309578): manufacturing dates: 08/07/2017 to 08/08/2017.Batch quantity was 705,600.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 7212714 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.Investigation conclusion: based on the severity and occurrence a root cause is not necessary.Add¿l information: lot # provided: 7212714, medical device expiration date: 07-31-2022, device manufacture date: 08/12/2017.

• 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: 7314872
• Report Number: 1213809-2018-00136
• Device Sequence Number: 13480069
• Product Code: FMF
• UDI-Device Identifier: 30382903095781
• UDI-Public: 30382903095781
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

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: 07/31/2022
• Device Catalogue Number: 309578
• Device Lot Number: 7212714
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 04/03/2018
• 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