MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ SYRINGE AND NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305906
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd safetyglide¿ syringe and needle had a crack in the syringe.It was unspecified whether the device was cracked before during or after use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Lot # provided: 7156651.Medical device expiration date: 05/31/2022.Device manufacture date: 07/01/2017.Investigation results: sample evaluation: a single 3ml syringe in an opened package was received and confirmed to be from batch #7156651 (p/n 305906).It was visually evaluated.The package the sample arrived in, including the envelope and the sample bag was damaged in transit.The damage penetrated the bags and damaged the sample itself, causing barrel damage near the flange.Likely unrelated to the handling damage, a crack in the barrel was observed extending from the barrel collar to the 1 ½ ml line outside the scale markings.Dhr review for batch 7156651 (p/n 305906): manufacturing dates: 6/17/2017 to 6/27/2017.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 7156651 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Based on the sample evaluation bd canaan was able to confirm the customer's indicated failure.A potential root cause is that the barrel was likely cracked at one of the pinch points between the printing and packaging processes.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 SAFETYGLIDE¿ SYRINGE AND NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7267830
• Report Number: 1213809-2018-00034
• Device Sequence Number: 1368420
• Product Code: FMI
• UDI-Device Identifier: 00382903059065
• UDI-Public: 00382903059065
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• 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
• 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 Expiration Date: 05/31/2022
• Device Catalogue Number: 305906
• Device Lot Number: 7156651
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/13/2018
• 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