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

Catalog Number	8881135609
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris¿ pca module set empty monoject¿ syringe barrel iv set assembly foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter.Reported issue per customer: excess unknown solution was observed around the ribcage and above the rubber stopper of the syringe barrel.Customer has 5 full cases and 1 partial case that has 11 packs of 10 each which equals the 860 each.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of foreign matter could not be verified due to the product not being returned for failure investigation.A device history record review for model 8881135609 lot number 2213015864 was performed by the supplier.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported while using bd alaris¿ pca module set empty monoject¿ syringe barrel iv set assembly foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: reported issue per customer: excess unknown solution was observed around the ribcage and above the rubber stopper of the syringe barrel.Customer has 5 full cases and 1 partial case that has 11 packs of 10 each which equals the 860 each.

• Brand Name: BD ALARIS¿ PCA MODULE SET EMPTY MONOJECT¿ SYRINGE BARREL IV SET ASSEMBLY
• Common Device Name: PISTON SYRINGE
• 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 ; 8448235433
• MDR Report Key: 16718740
• Report Number: 2243072-2023-00599
• Device Sequence Number: 1649498
• Product Code: FMF
• UDI-Device Identifier: 20884521155746
• UDI-Public: (01)20884521155746
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: 2213015864
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• 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