MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTORS P53; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515107

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

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 the expansion chamber of the bd phaseal¿ protectors p53 wasn't working.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

One sample unit was received for evaluation by our quality engineer team.Upon visual inspection of the sample, the expansion chamber was observed damaged.The film of the expansion chamber was broken, therefore, the expansion chamber could not inflate properly.A device history record review did not reveal any documented quality issues during the production of lot number 1604017 that could have contributed to the reported/observed defect.A station within the assembly machine is designed to detect damaged expansion chamber film.If detected, the product in question would have been rejected.Although an exact cause cannot be determined, it does not appear likely that the defect occurred during the manufacturing process.Investigation conclusion: the report confirms that the expansion chamber is broken: there is no evidence on the dhr about any problem during the manufacturing process (no non-conformances, no maintenance interventions).On the other hand, the p3 assembly machine can detect if the film is broken (station #19).In this case, the piece would be rejected.Based on this, it doesn¿t seem likely that the defect have taken place during manufacturing process.The root cause cannot be determined.

Event Description

It was reported that the expansion chamber of the bd phaseal¿ protectors p53 wasn't working.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD PHASEAL¿ PROTECTORS P53
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7861430
• MDR Text Key: 119827288
• Report Number: 3003152976-2018-00398
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151072
• UDI-Public: 30382905151072
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

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: 03/31/2021
• Device Catalogue Number: 515107
• Device Lot Number: 1604017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other