MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGE

Catalog Number	304416
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/01/2017
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: 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 plungers on bd¿ slip tip syringe(s) were broken prior to use.There was no report of injury or medical interventions.
Additional Manufacturer Narrative
Investigation results: dhr review for batch 7002731 (p/n 304416): manufacturing dates: 02/01/2017.Batch quantity was (b)(4).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 7002731 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.(b)(4) loose 5ml assembled syringes were received by bd (b)(4) and reported to be from batch # 7002731.The samples were visually evaluated.The syringes were all found to have broken plunger rod rib.The affected area was approximately l2/3 the length of the plunger rod rib.Some samples had a larger affected area than others.In all of the samples only one plunger rod rib was affected.In (b)(4) of the samples the rib remained attached while in 13 of the samples, the broken portion of the rib was detached.Probable root cause: the damage observed is likely a result of a component jam in the assembly machine.Once a part is caught outside its path, each passing plunger rod is then potentially damaged by the jammed component.One of the common causes of jams is a misalignment of the component guide.Investigation revealed that this assembly machine does not have an alignment piece that is present on other machines that helps to reduce the occurrence of jams by ensuring constant guide alignment.Preventive actions: alignment piece will be installed at the plunger rod guides to ensure alignment during assembly on this machine.Complaints will be tracked and tended for this defect on this manufacturing line following implementation.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of trends.

• Brand Name: BD¿ SLIP TIP SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7139028
• Report Number: 1213809-2017-00376
• Device Sequence Number: 1238684
• Product Code: FMF
• UDI-Device Identifier: 50382903044165
• UDI-Public: 50382903044165
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

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: 304416
• Device Lot Number: 7002731
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/27/2018
• 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