MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515111

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported that when attaching a bd phaseal¿ protector p50j to vial the connection was incomplete.The following information was provided by the initial reporter, translated from (b)(6) to english: when attaching the protector to a vial, the hcp noticed that adhesive glueing of the expansion chamber film was poor/incomplete.An anticancer agent was adhering to the actual sample returned for investigation (no information on the drug name was provided).

Manufacturer Narrative

Medical device expiration date: unknown.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.

Manufacturer Narrative

Medical device expiration date: unknown.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 when attaching a bd phaseal¿ protector p50j to vial the connection was incomplete.The following information was provided by the initial reporter, translated from (b)(6) to english: when attaching the protector to a vial, the hcp noticed that adhesive glueing of the expansion chamber film was poor/incomplete.An anticancer agent was adhering to the actual sample returned for investigation (no information on the drug name was provided).

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2021-12-29.H6: investigation summary sample received for investigation.The product was visually inspected, observing that the oval of the bladder was cracked/broken, leaving open the seal of the film that makes the bell of the protector watertight.The lot number is unknown, so the device history record review (dhr) and quality notification (qn) review could not be performed.The breakage could be due to several unusual occurrences 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 process of transport or in the same clinic of use.However, without the batch number, it is not possible to investigate if any of these jams have occurred during the production of the batch, so it is not possible to find a root cause in our manufacturing process.

Event Description

It was reported that when attaching a bd phaseal¿ protector p50j to vial the connection was incomplete.The following information was provided by the initial reporter, translated from japanese to english: when attaching the protector to a vial, the hcp noticed that adhesive glueing of the expansion chamber film was poor/incomplete.An anticancer agent was adhering to the actual sample returned for investigation (no information on the drug name was provided).

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12864789
• MDR Text Key: 285474296
• Report Number: 3003152976-2021-00785
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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