MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-15123-F

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that 2 days after insertion, the third line of the catheter was cut.There was no clinical consequence for the patient as it happened during the replacement of the bandage.

Manufacturer Narrative

Qn# (b)(4).The customer returned a single 3-lumen cvc catheter for evaluation.The distal extension line hub was returned separated from the hub.The distal extension line slide clamp was not returned.Dried blood was observed in the catheter body.Visual examination revealed the distal extension line had separated adjacent to the distal hub.Extension line material was observed within the luer hub, although no material was protruding out of the hub.The remaining material was rough/jagged indicating a tear due to excessive force.The material at the end of the extension line still attached to the juncture hub was smooth and clean indicating a break due to contact with a sharp instrument (i.E.Scissors, scalpel).Dimensional inspection revealed that a portion of the distal extension line is missing and was not returned, therefore, it is likely two breakages occurred on the distal line.The break at the luer hub appears to be consistent with a break due to excessive force and the break at the center of the extension line appears to be consistent with contact with a sharp instrument.Possible residual adhesive material was observed on the distal extension line body.No defects were observed on the proximal and medial extension lines, the juncture hub or the catheter body.(con't) other remarks: the length of the distal extension line connected to the juncture hub measured 46 mm.None of the extension line body protruded out of the separated luer hub.The two combined lengths are not consistent with the nominal length specification (58 mm) for the medial extension line, indicating that an additional separated piece is missing (approximately 22 mm) and was not returned.The distal extension line outer and inner diameter were measured and both were within specification.A manual tug test confirmed the proximal and medial extension lines are secure.A device history record review was performed on the catheter including the distal extension line and no manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit cautions the user "alcohol and acetone can weaken the structure of polyurethane material.Therefore, care should be taken when instilling drugs containing alcohol or when using high concentration of alcohol or acetone when performing routine catheter care and maintenance.Alcohol should not be utilized to de-clot polyurethane catheters." the ifu also contains the cautions "to minimize the risk of damage to extension lines from excessive pressure, each clamp must be opened prior to infusing through that lumen" as well as "to minimize the risk of cutting the catheter do not use scissors to remove the dressing." the report that the luer hub separated from the catheter was confirmed by visual examination of the returned sample.Dimensional inspection revealed that there was likely two breakages in the distal extension line; one adjacent to the distal luer hub and one at the center of the distal extension line.Visual examination determined the break at the luer hub appears to be consistent with a break due to excessive force and the break at the center of the extension line appears to be consistent with contact with a sharp instrument.Based on the appearance of the luer hub and distal extension line and the report that the event occurred during use, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that 2 days after insertion, the third line of the catheter was cut.There was no clinical consequence for the patient as it happened during the replacement of the bandage.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7189212
• MDR Text Key: 97494252
• Report Number: 3006425876-2018-00035
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: CS-15123-F
• Device Lot Number: 71F16M1590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1