MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P21; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515102
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2019
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 protector p21 experienced needle separation on protector prior to use.The following information was provided by the initial reporter: upon opening of the packaging, the pharmacist notice there's lost of needle after removing the cap of the protector.Thus, the product could not be use.Updated info: the needle was not in the packaging.
Additional Manufacturer Narrative
Investigation summary: one photo sample was provided to our quality team for investigation.Through visual inspection, it was verified the protector did not have the cannula assembled.No defects or damage could be observed on the needle housing.A device history was performed and found no no-conformances related to the reported issue during production of batch 1704122.Product undergoes visual and functional inspections throughout the manufacturing process to ensure the quality of the device, including controls to verify the cannula presence, length, and position.These controls were tested with a protector that did not have a cannula, such as the product you reported.All product was properly discarded, verifying the controls function as intended.Five retained samples of the same lot were used for additional evaluation, no defects were observed upon visual inspection.Based on the available information we are not able to determine a root cause at this time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that the protector p21 experienced needle separation on protector prior to use.The following information was provided by the initial reporter: upon opening of the packaging, the pharmacist notice there's lost of needle after removing the cap of the protector.Thus, the product could not be use.Updated info: the needle was not in the packaging.

• Brand Name: PROTECTOR P21
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8742130
• Report Number: 3003152976-2019-00428
• Device Sequence Number: 11404508
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 515102
• Device Lot Number: 1704122
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other