MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PCA ASV MICROBORE CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30873
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 asv microbore cv leakage occurred from a crack.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they found the pca tubing cracked and leaking from where the trifuse meets.Bd pca administration set ref# 30873 ¿ the nurse went into a patient¿s room and found the pca tubing leaking and found a ¿crack¿ where the trifuse meets the pca tubing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, returned to manufacturer on: 04-oct-2022.Investigation summary: one sample was submitted for quality investigation.The customer complaint of component damage - leak was verified by investigation.Visual inspection of the tubing and connectors revealed that there was a crack, running along the longitudinal axis of the female luer connector.The root cause for the crack in the tubing could not be fully determined based on the information provided by the customer.A device history record review could not be performed because the lot number is unknown.The probable root cause for the failure is that the luer was tightened with too much force causing the body of the female luer adapter to crack to due to the stress applied.
Event or Problem Description
It was reported while using bd alaris¿ pca asv microbore cv leakage occurred from a crack.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that they found the pca tubing cracked and leaking from where the trifuse meets.Bd pca administration set ref# 30873 ¿ the nurse went into a patient¿s room and found the pca tubing leaking and found a ¿crack¿ where the trifuse meets the pca tubing.

• Brand Name: BD ALARIS¿ PCA ASV MICROBORE CV
• Common Device Name: 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: 15316253
• Report Number: 9616066-2022-01238
• Device Sequence Number: 14924571
• Product Code: FPA
• UDI-Device Identifier: 10885403273940
• UDI-Public: 10885403273940
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 11/07/2022

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
• Operator of Device: Other
• Device Catalogue Number: 30873
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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