MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); IV SET

Catalog Number 515312

Device Problem Deflation Problem (1149)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd phaseal secondary set (c62) cracked.The following information was provided by the initial reporter: "before use, the pharmacist pulled out the c62 and noticed that there is a defect with the tubing.It was sealed shut by the sealing machine for the packaging.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes,.D10: returned to manufacturer on: 2021-10-18.H6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, a cut in the tubing was observed.A device history review was performed and found no non-conformances associated with this issue during the production of this batch.Product undergoes visual inspections according to procedure, no issues were identified during manufacturing related to this defect, the product was verified to be manufactured according to specifications.The set is manually assembled and inserted into the machine, which seals the paper to form the unit packaging.If the product is not placed correctly into the machine, it is possible the tubing can become damaged during this process.A system is used to notify the operator if the product is improperly placed to avoid any damage to the product.While we could not identify a direct issue, it was determined that this issue likely occurred as a result the operator not properly placing the product in the machine and failing to then discard the impacted unit after the issue was detected.

Event Description

It was reported that bd phaseal secondary set (c62) cracked.The following information was provided by the initial reporter: "before use, the pharmacist pulled out the c62 and noticed that there is a defect with the tubing.It was sealed shut by the sealing machine for the packaging.".

• Brand Name: BD PHASEAL SECONDARY SET (C62)
• Type of Device: IV 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: 12733828
• MDR Text Key: 279580086
• Report Number: 3003152976-2021-00721
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515312
• Device Lot Number: TA12140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2021
• 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