MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P14J; PHASEAL ADMINISTRATION SET

Catalog Number 515109

Device Problem Leak/Splash (1354)

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

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd phaseal¿ protector p14j were leaked during use.

Manufacturer Narrative

Correction: describe event or problem: it was reported that two bd phaseal¿ protector p14j leaked during use.Date/time and or patient information is unknown.Investigation summary: two sample units were received for evaluation by our quality engineer team.Lot number unknown therefore complaint history check cannot be performed.Investigation conclusion: through visual inspection of the samples, no defects were observed on the samples, there were no signs of leakage between either the injector, the protector, or the vial, and no damages were observed to the membranes.Root cause description: based on the investigation results, an exact cause could not be determined for this incident.Use of the m12 assembly fixture is recommended to ensure a proper connection is made with the protector product.The protector must be connected completely vertically to the vial.Rationale: complaints received for this device will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that two bd phaseal¿ protector p14j leaked during use.Date/time and or patient information is unknown.

Event Description

It was reported that bd phaseal¿ protector p14j were leaked during use.

Manufacturer Narrative

Correction: in section h.10 of the previously submitted mdr, sections d.1 and h.1 were incorrectly referenced as the medical device expiration date and device manufacture date.

• Brand Name: BD PHASEAL¿ PROTECTOR P14J
• Type of Device: PHASEAL ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8204498
• MDR Text Key: 131768167
• Report Number: 3003152976-2018-00574
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00382905151095
• UDI-Public: 382905151095
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515109
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other