MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P53J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515112

Device Problems Crack (1135); Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported that the bd phaseal¿ protector p53j packaging unit was open, and the device had a crack in the expansion chamber.These events also occurred with 2 other protectors.The following information was provided by the initial reporter, translated from (b)(6): "the customer reported the following two issues of protector: (1) package seal integrity: some packages were open.(2) cracked: a crack was found near the expansion chamber." "the package was found to be a bit open before use.While being suspicious about it, the hcp opened this package, and discovered a crack on the housing at the root of the expansion chamber.The hcp then discovered that the two other packages were also a bit open; when opening these packages, the hcp discovered a crack on the housing at the root of these expansion chambers as well.".

Manufacturer Narrative

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

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 bd phaseal¿ protector p53j packaging unit was open, and the device had a crack in the expansion chamber.These events also occurred with 2 other protectors.The following information was provided by the initial reporter, translated from (b)(6): "the customer reported the following two issues of protector: (1) package seal integrity: some packages were open.(2) cracked: a crack was found near the expansion chamber." "the package was found to be a bit open before use.While being suspicious about it, the hcp opened this package, and discovered a crack on the housing at the root of the expansion chamber.The hcp then discovered that the two other packages were also a bit open; when opening these packages, the hcp discovered a crack on the housing at the root of these expansion chambers as well.".

Event Description

It was reported that the bd phaseal¿ protector p53j packaging unit was open, and the device had a crack in the expansion chamber.These events also occurred with 2 other protectors.The following information was provided by the initial reporter, translated from japanese: "the customer reported the following two issues of protector: package seal integrity: some packages were open.Cracked: a crack was found near the expansion chamber."."the package was found to be a bit open before use.While being suspicious about it, the hcp opened this package, and discovered a crack on the housing at the root of the expansion chamber.The hcp then discovered that the two other packages were also a bit open; when opening these packages, the hcp discovered a crack on the housing at the root of these expansion chambers as well.".

Manufacturer Narrative

H.6.Investigation: three samples were received for investigation.The product was visually inspected, noting that the housing was perfectly cracked/broken, not being properly assembled in the vial.No sample or photograph was received for the open container failure or seal integrity failure, which could not be evaluated or investigated.A review of the device history was performed for the reported lot 2007133, no deviations or nonconformities were identified during the manufacturing process that could have contributed to these problems.In addition, fifty retained samples from the same lot were evaluated and no part damage or blister defects related to seal integrity were observed.Breaks can be caused by a variety of unusual events, such as a jam in the shield assembly machine or a jam in the packaging line.It could also be the case of a blow or damage in the transport process or in the use clinic itself.However, it is not possible to confirm whether any of these jams have occurred during batch production, so it is not possible to find a root cause in our manufacturing process.

• Brand Name: BD PHASEAL¿ PROTECTOR P53J
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13156102
• MDR Text Key: 285622983
• Report Number: 3003152976-2021-00877
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515112
• Device Lot Number: 2007133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 03/29/2022
• Supplement Dates FDA Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2020
• 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