MAUDE Adverse Event Report: BECTON DICKINSON PCA ASV MICROBORE CV; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	30873
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 30873.Batch # unknown.It was reported by customer that the recent upgrade of the alaris pumps, nurses are having occlusion issues with the pca set.Verbatim: rcc received a complaint via email.Email(s) attached.Requesting troubleshooting assistance with the alaris pca set (ref 30873).States since the recent upgrade of the alaris pumps, nurses are having occlusion issues with the pca set.The alarm states occlusion on the patient side and it has happened with at least 50% of their patients.
Event or Problem Description
Material # 10800175.Batch # 24066698.It was reported by customer that the recent upgrade of the alaris pumps, nurses are having occlusion issues with the pca set.Verbatim: rcc received a complaint via email.Requesting troubleshooting assistance with the alaris pca set (ref 30873).States since the recent upgrade of the alaris pumps, nurses are having occlusion issues with the pca set.The alarm states occlusion on the patient side and it has happened with at least 50% of their patients.Customer response on december 03, 2024.1.In your previous response, it was mentioned that the most recent event date was (b)(6) 2024.Could you please confirm if any earlier events were reported to bd? if so, please provide the complaint number.If not, could you provide the event dates in the format (mm-dd-yyyy), if available? this event also occurred on (b)(6) 2024, (b)(6) 2024, and (b)(6) 2024.There were additional event dates, but these are the only dates in which it was directly reported to me.Meredith- do you have a complaint number from the report that you previously made with technical support? 2.The provided lot# 24066698 does not match with material# 30873 but corresponds to material# 10800175.Could you please reconfirm the lot number? yes, the lot number above corresponds with the pca administration set ref: 10800175.I do not know what material #30873 is referencing.Is this for a bd product other than the pca administration set? if you can let me know specifically what product you would like the lot number for, i may be able to better assist.Customer response on december 17, 2024.1) yes, the referring material number "30873" is belongs to bd product (material description for the material number "30873" is pca set y conn check vlv 90 inch.) can you please provide the lot number for the material number "30873"? we do not use any bd pca product with the material number of 30873, so i am unable to provide a lot number for this.The only pca set that is used in the facility is the pca kit with a material number 10800175 and lot number 24066698.2) outcome of second follow-up, the lot number provided by the customer "24066698" is referring to material description ("pca kit y conn check vlv 90 inch") for material number "10800175" can you please confirm with the customer which material number ("30873" or "10800175") was affected one? as stated previously, the material number affected is 10800175.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for material#10800175 and lot# 24066698 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24jun2024.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.

• Brand Name: PCA ASV MICROBORE CV
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20895401
• Report Number: 9616066-2024-02012
• Device Sequence Number: 15434209
• Product Code: FPA
• UDI-Device Identifier: 10885403273940
• UDI-Public: (01)10885403273940
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2024

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: Health Professional
• Device Catalogue Number: 30873
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown