MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ SECONDARY SET C61; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515302
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is cazin, bosnia.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter e-mail: unknown a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 bd phaseal¿ secondary sets c61 had damaged tubing that was sliced open through the packaging.The following information was provided by the initial reporter: "3 units of c61 were sliced due to packaging error.".
Event or Problem Description
It was reported that 3 bd phaseal¿ secondary sets c61 had damaged tubing that was sliced open through the packaging.The following information was provided by the initial reporter: "3 units of c61 were sliced due to packaging error.".
Additional Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 1022262.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.During examination of retain samples, no defect has been noticed.Sample have no issues.Additionally a photograph was provided which displayed a sealed empty packaging unit.The issue has been confirmed.Based on the image our engineers were able to directly associated this issue with the manual packaging process.To prevent future occurrences the appropriate personnel have been notified of this event.

• Brand Name: BD PHASEAL¿ SECONDARY SET C61
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15580808
• Report Number: 2243072-2022-01753
• Device Sequence Number: 17759962
• Product Code: FPA
• UDI-Device Identifier: 00382905153020
• UDI-Public: (01)00382905153020
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 515302
• Device Lot Number: 1022262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown