MAUDE Adverse Event Report: BECTON DICKINSON BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	8881135609
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ pca module set empty monoject¿ syringe barrel iv set assembly experienced foreign matter within the fluid path.This complaint was created to capture the 6th of 6 related incidents.The following information was provided by the initial reporter: fiber in solution, inside barrel of syringe.
Additional Manufacturer Narrative
Oem manufacture: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following information has been corrected: oem manufacture: the manufacturing location for this product is covidien.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that blue particles were found in one bd alaris¿ pca module set empty monoject¿ syringe barrel iv set assembly, fiber was found in the solution of another syringe, and particles were found in the barrel of another syringe with greasy substance.This complaint was created to capture the 2nd of 6 related incidents.The following information was provided by the initial reporter: "blue particle in plastic of container, inside" "fiber in solution, inside barrel of syringe" "particles in barrel of syringe, between septum and barrel, with greasy substance present".
Additional Manufacturer Narrative
H6: investigation summary: a complaint of syringes having foreign matter as well as a misaligned plunger was received from the customer.Photos were provided for investigation.In the photos, foreign matter can be seen on the syringes.The customer complaint was confirmed.The device history record was reviewed at the supplier, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during production process.The supplier was notified of this defect.The photos were sent to the supplier and they were able to confirm foreign matter as the defect.The misaligned plunger condition could not be confirmed.A walkthrough was performed of the manufacturing process.All process and controls were found properly followed, including sub-assemblies, finished product assemblies, packaging and inspections performed to the product.In addition, qc inspections are performed to the product for material release; and production personnel performs a 100% visual inspection during the packaging process, in order to defect and discard any identified failures.Based on the available information, it is not possible to confirm the source of the contamination without a physical evaluation.
Event or Problem Description
It was reported that the bd alaris¿ pca module set empty monoject¿ syringe barrel iv set assembly experienced foreign matter within the fluid path.This complaint was created to capture the 6th of 6 related incidents.The following information was provided by the initial reporter: fiber in solution, inside barrel of syringe.

• Brand Name: BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY
• 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: 15884237
• Report Number: 2243072-2022-02060
• Device Sequence Number: 5123156
• Product Code: FPA
• UDI-Device Identifier: 20884521155746
• UDI-Public: 20884521155746
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2023

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: 8881135609
• Device Lot Number: 2203502364
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 12/15/2022; 01/25/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 12/30/2022; 02/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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