MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60; CLOSED DRUG DELIVERY SYSTEM

Catalog Number	515301
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/09/2018
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 a bd phaseal¿ secondary set drip chamber c60 had roller clamp that did not fully engage and leaked.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
One picture sample was received for evaluation by our quality engineer.Upon visual inspection of the picture, the tubing was observed to be poorly positioned within the roller clamp.The connector component is manufactured within a bd facility.Dhr review - lot number 371088, product code (b)(4).During the connector assembly and molding process, regular inspections are performed to ensure product is within specifications.As the secondary set is manufactured at a subcontractor location, a complaint was sent to the subcontractor for this incident.No non-conformances were found during the manufacturing process that could have contributed to the reported issue.As no evidence was found to link this defect to the manufacturing process, it was concluded by the subcontractor that the defect was a result of incorrect device usage.Based on the provided picture, the most likely cause for the defect is incorrect manipulation during handling.If the roller clamp is not rolled straight down, but instead pushed side to side, the roller may move outside of the rails.Based on the frequency of the defect no more actions are needed.
Event or Problem Description
It was reported that a bd phaseal secondary set drip chamber c60 had roller clamp that did not fully engage and leaked.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD PHASEAL¿ SECONDARY SET DRIP CHAMBER C60
• Common Device Name: CLOSED DRUG DELIVERY SYSTEM
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7828103
• Report Number: 3003152976-2018-00372
• Device Sequence Number: 11182072
• Product Code: ONB
• UDI-Device Identifier: 00382905153013
• UDI-Public: 382905153013
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 07/31/2021
• Device Catalogue Number: 515301
• Device Lot Number: 371088
• Initial Date Received by Manufacturer: 08/09/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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