MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MALE LL ADAPTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 1001-187-004

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd male ll adaptor had foreign matter.The following information was provided by the initial reporter: burn/black specs.

Event Description

It was reported that the bd male ll adaptor had foreign matter.The following information was provided by the initial reporter: burn/black specs.

Manufacturer Narrative

H6: investigation summary a complaint of foreign matter was received from the customer.116 pieces were sampled, and 9 pieces were found with the failure mode reported.A photo of this defect was provided by the customer.Dark embedded specks could be seen on the male luers.The defect was confirmed.There has been 1 qn documented between (b)(6) 2020 to (b)(6)2022 for part number 1001-187-004 and batch number 0270001.This qn was opened for multiple missed cleanings of the equipment for this material number.After reviewal with the molding and process engineering group of the defective parts, it was noted that this defect is "embedded fm" and not burn marks.During the batch record review, it was noted that one of the qns was for "missed cleanings".The potential causes of embedded fm in injection molding are degraded material from down-time/ start up, mold barrel/ nozzle being unclean due to a buildup of residue at the screw and manifold area, or the resin itself containing impurities that have contaminated it.The affected batch was produced in (b)(6) 2020.Since production of this batch, the mold is programmed to run an adequate number of shots to scrap before collecting samples for good product at a machine start-up.A historical review of qns for this mold from (b)(6) 2020 to (b)(6) 2022 has show there have been no other instances of customer complaints or quality notifications related to this condition for the mold.H3 other text : see h10.

• Brand Name: BD MALE LL ADAPTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15244802
• MDR Text Key: 305146216
• Report Number: 9616066-2022-01185
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

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
• Device Operator: Other
• Device Catalogue Number: 1001-187-004
• Device Lot Number: 0270001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/17/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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