MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515202

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd phaseal¿connector leaked.No serious injury or medical intervention was reported.

Event Description

It was reported that bd phaseal¿connector leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: fifty-seven sample units belonging to lot number 1707001 were received for evaluation by our quality engineer.A device history record review was performed on the provided lot number and no quality issues were found during the production process that may have contributed to the reported incident.Investigation conclusion: visual inspection was performed on the returned samples and no defects were observed.Leakage testing was performed on twenty of the returned samples and no signs of leakage were found through the phaseal membrane.Five of the samples were connected to infusions sets and the connectors worked per specification with no signs of leakage.Root cause description: based on the investigation results, the reported incident could not be replicated and therefore, an exact cause for the reported incident could not be determined.Rationale: the performance of the sealing membrane is reduced after multiple perforations and extended activation time.It is recommended that no more than ten perforations are performed.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL¿CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8196497
• MDR Text Key: 131497515
• Report Number: 3003152976-2018-00563
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

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: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 515202
• Device Lot Number: 1707001
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other