MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P55); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515117
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd phaseal¿ protector (p55) had a small, sharp, plastic protrusion on the spike that fell into the bottle during the puncture.The sharp molding defect event occurred with 30 protectors.The following information was provided by the initial reporter, translated from german: "the piercing spike has a small plastic tip that enters the bottle during piercing.Customer informs us that when using ari.515117, it was noticed that a small plastic tip protrudes from the puncture spike, which gets into the bottle when puncturing.As a result, about 100 protectors were opened, of which a good 30 are affected.The batch has now been put to one side.It seems that the puncture spike was not designed properly during production.".
Event or Problem Description
It was reported that the bd phaseal¿ protector (p55) had a small, sharp, plastic protrusion on the spike that fell into the bottle during the puncture.The sharp molding defect event occurred with 30 protectors.The following information was provided by the initial reporter, translated from german: "the piercing spike has a small plastic tip that enters the bottle during piercing.Customer informs us that when using ari.515117, it was noticed that a small plastic tip protrudes from the puncture spike, which gets into the bottle when puncturing.As a result, about 100 protectors were opened, of which a good 30 are affected.The batch has now been put to one side.It seems that the puncture spike was not designed properly during production.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 28-dec-2022.H6: investigation summary several samples were provided to our quality team for investigation.Through visual inspection, the tip of the protector spike is observed to be bent in all of the samples.The shank of the protector was inspected and no damage or other issues were identified.Three retained samples were used for additional evaluation.All product was inspected and no damage was observed on any of the protector spikes.A device history review was performed for the reported lot 2201140, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, no issues were identified during manufacturing.

• Brand Name: BD PHASEAL¿ PROTECTOR (P55)
• Common Device Name: 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: 15544476
• Report Number: 3003152976-2022-00455
• Device Sequence Number: 6511790
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123213
• 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): 01/11/2023

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 Catalogue Number: 515117
• Device Lot Number: 2201140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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