MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35C; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 "small rubber pieces" were seen in the bd phaseal¿ injector luer lock n35c.
Additional Manufacturer Narrative
Investigation summary: one protector sample with a vial was received for evaluation by our quality team.For the injector product, lot number 1805107 was provided for evaluation.For the protector product, lot number 1807112 was provided for evaluation.A device history record review did not reveal any quality issues during the production of lot number 1805107 or 1807112 that could have contributed to the reported incident.Through visual inspection of the returned sample, fragments of the rubber stopper were found within the filtered drug.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.No defects were observed to the protector needle.Based on the investigation results, a definite cause could not be determined for this incident.Use of the m12 assembly fixture is recommended to ensure proper connection of the protector product.A corrective and preventive action plan has been initiated to further investigate this issue and reduce its reoccurrence.The complaint is confirmed: fm was found inside the vial.It is part of the rubber stopper.No defect was found in the needle of protector.The root cause cannot be determined.
Event or Problem Description
It was reported that "small rubber pieces" were seen in the bd phaseal¿ injector luer lock n35c.

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35C
• 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: 8156002
• Report Number: 3003152976-2018-00529
• Device Sequence Number: 1997168
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 10/31/2020
• Device Catalogue Number: 515004
• Device Lot Number: 1805107
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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