MAUDE Adverse Event Report: BECTON DICKINSON UNSPECFIED BD PHASEAL¿; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Delivered as Unsterile Product (1421)

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

Event Date 05/27/2019

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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd phaseal¿ device began leaking from the y-site curos cap during a cytarabine infusion, and the cap was replaced and the infusion restarted.Around 30 minutes later, an alert went off and the phaseal device at the patient picc site was found opened, which had to be reconnected with pressure and a clamp.This complaint was created to capture the 1st of 5 related incidents.The following information was provided by the initial reporter: "observed pt continuous iv cytarabine infusion to be leaking from y-site curos cap.Cap replaced and infusion restarted uneventfully.Called into patient about a half hour later when beeping "downstream", phaseal at pt picc site was found to be open.Phaseal reconnected with some pressure and clamp placed, infusing without incident at present.".

Event Description

It was reported that the unspecfied bd phaseal¿ device began leaking from the y-site curos cap during a cytarabine infusion, and the cap was replaced and the infusion restarted.Around 30 minutes later, an alert went off and the phaseal device at the patient picc site was found opened, which had to be reconnected with pressure and a clamp.This complaint was created to capture the 1st of 5 related incidents.The following information was provided by the initial reporter: "observed pt continuous iv cytarabine infusion to be leaking from y-site curos cap.Cap replaced and infusion restarted uneventfully.Called into patient about a half hour later when beeping "downstream", phaseal at pt picc site was found to be open.Phaseal reconnected with some pressure and clamp placed, infusing without incident at present.".

Manufacturer Narrative

Correction: the original reporting rationale for sterility was incorrect, and has been updated to loose injector or separation of injector and mating component.The following field has been corrected: f.10.Device codes: 1354 h3 other text : see section h.10.

Manufacturer Narrative

H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident and a root cause could be determined.A device history review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure h3 other text : see section h.10.

Event Description

It was reported that the unspecfied bd phaseal¿ device began leaking from the y-site curos cap during a cytarabine infusion, and the cap was replaced and the infusion restarted.Around 30 minutes later, an alert went off and the phaseal device at the patient picc site was found opened, which had to be reconnected with pressure and a clamp.This complaint was created to capture the 1st of 5 related incidents.The following information was provided by the initial reporter: "observed pt continuous iv cytarabine infusion to be leaking from y-site curos cap.Cap replaced and infusion restarted uneventfully.Called into patient about a half hour later when beeping "downstream", phaseal at pt picc site was found to be open.Phaseal reconnected with some pressure and clamp placed, infusing without incident at present.".

• Brand Name: UNSPECFIED BD PHASEAL¿
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8732740
• MDR Text Key: 149361788
• Report Number: 2243072-2019-01261
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 07/09/2019

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 05/31/2019; 05/31/2019
• Supplement Dates FDA Received: 07/03/2019; 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other