MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEM PORT INTRODUCER KIT

Catalog Number	EVPC62
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this event was not returned for evaluation.The complaint 10cc control syringe is part number wel1300-10cntl.A supplier corrective action (scar) was submitted to welmed, inc.(the supplier of the device) on may 7, 2024.Welmed fda registration number is 3005841027.A follow-up report will be provided upon conclusion of investigation and response by the supplier.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Event or Problem Description
There is foreign material in procedure pack.Lidocaine syringe has a hair between the handle and the syringe piston.The site threw away the entire pack, despite having multiple expensive items in it.The sterile field was compromised.The site indicated there was a 20 minute surgical delay as a result of incident.
Additional Manufacturer Narrative
Based on the results of the investigation, we could confirm the failure reported by the photograph provided.The evaluation process for components specifies that each component is inspected for any abnormalities during kit assembly.A device history record evaluation was performed, there were no non-conformances or issues noted during manufacture of complaint lot.This appears to be an isolated incident where the assembly teammate failed to detect the hair presence during verification processes.Based on the hair location, the syringe was likely received from the manufacturer with the hair attached to the syringe where piston is located.A supplier corrective action was issued to welmed communicating the complaint.Assembly operators were alerted and retrained on the importance of inspection processes for quality assurance.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.

• Brand Name: PORT INTRODUCER KIT
• Common Device Name: PORT INTRODUCER KIT
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEM; 2610 n.e. industrial drive; suite 220; kansas city MO 64117
• Manufacturer (Section G): WELMED, INC.; 401 n michigan avenue; ste 1200; chicago IL 60611
• Manufacturer Contact: nichole early ; 2610 n.e. industrial drive; suite 220; kansas city, MO 64117 ; 8287820529
• MDR Report Key: 19314361
• Report Number: 3003419114-2024-00001
• Device Sequence Number: 7010050
• Product Code: OKE
• UDI-Device Identifier: 00191072209733
• UDI-Public: 00191072209733
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: EVPC62
• Device Lot Number: 954241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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