MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515070

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ connector disconnected.This occurred on 3 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no: unknown batch no: unknown (reported 1904103 which does not reference to a c35-o).It was reported that infusion disconnected at the connector/injector connection close to the 24hr mark.Patient was receiving a 24hr infusion on an ip unit.Infusion disconnected at the connector/injector connection close to the 24hr mark.No leak occurred, and no patient or nurse injury.

Manufacturer Narrative

The following fields have been updated with additional information: site legal name (fda): (b)(6).D.1.Medical device brand name: bd phaseal¿ optima system, connector, c35-o.D.2.Medical device type: onb.D.2.Common device name: intravascular administration set.D.3.Medical device manufacturer: (b)(6).D.2.Medical device catalog #: 515070 d.4.Medical device expiration date: 2020-03-31 d.4.Medical device lot #: 1904103 d.4.Unique identifier (udi) #:(b)(4).G.1.Manufacturing location: (b)(6).G.5.Pma/510(k)#: k181221.H.4.Device manufacture date: 2019-04-29.

Event Description

It was reported that bd phaseal¿ optima system, connector, c35-o disconnected.This occurred on 3 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no: unknown batch no: unknown (reported 1904103 which does not reference to a c35-o) it was reported that infusion disconnected at the connector/injector connection close to the 24hr mark.Patient was receiving a 24hr infusion on an ip unit.Infusion disconnected at the connector/injector connection close to the 24hr mark.No leak occurred, and no patient or nurse injury.

Event Description

It was reported that bd phaseal¿ optima system, connector, c35-o disconnected.This occurred on 3 occasions during use.No date/time or patient information was given.The following information was provided by the initial reporter: material no: unknown batch no: unknown (reported 1904103 which does not reference to a c35-o) it was reported that infusion disconnected at the connector/injector connection close to the 24hr mark.Patient was receiving a 24hr infusion on an ip unit.Infusion disconnected at the connector/injector connection close to the 24hr mark.No leak occurred, and no patient or nurse injury.

Manufacturer Narrative

H.6.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1904103, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Functional testing was performed, engaging and disengaging the connectors and sample injectors from lot 1807712.In all cases the product functioned properly, and no issues were observed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging.H3 other text : see section h.10.

• Brand Name: BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix NJ 07417
• MDR Report Key: 8879519
• MDR Text Key: 154039057
• Report Number: 2243072-2019-01652
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: K181221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 515070
• Device Lot Number: 1904103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/09/2019
• Supplement Dates Manufacturer Received: 07/25/2019; 07/25/2019
• Supplement Dates FDA Received: 08/15/2019; 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other