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

Catalog Number UNKNOWN

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use of the unspecified bd phaseal¿ two phaseal protectors broke when attempting to cap the vial.As reported: while at doctors last week during our trial of optima i witnessed two protectors (p13) break that appeared to be misaligned and that is why they broke.The spike appears to have hit the side of the vial when trying to ¿cap¿ the vial.

Manufacturer Narrative

Investigation: no photos or physical samples that display the reported condition were available for investigation.As a lot number was unavailable for this incident, a device history record review could not be completed and additional retained samples could not be investigated.Per the description of the complaint it seems that the protector was not properly attached to the vial: ¿two protectors (p13) break that appeared to be misaligned and that is why they broke.The spike appears to have hit the side of the vial when trying to ¿cap¿ the vial.¿ please note that the protector must be vertically attached to the vial.If the attachment is not properly done at the center (through the rubber stopper), the spike could get damaged with the metallic cap.The root cause of the defect seems to be a user error during the connection.

Event Description

It was reported that during use of the unspecified bd phaseal¿ two phaseal protectors broke when attempting to cap the vial.As reported:while at doctors last week during our trial of optima i witnessed two protectors (p13) break that appeared to be misaligned and that is why they broke.The spike appears to have hit the side of the vial when trying to ¿cap¿ the vial.

• Brand Name: UNSPECIFIED BD PHASEAL¿
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8404273
• MDR Text Key: 139217564
• Report Number: 2243072-2019-00453
• Device Sequence Number: 0
• Product Code: FOZ
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• 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
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other