MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 6"; ARROWG+ARD CATHETER PRODUCTS

Catalog Number ASK-42854-PMGH

Device Problem Contamination (1120)

Patient Problem Tissue Breakdown (2681)

Event Date 06/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information was received via medwatch (b)(4).

Event Description

It was reported that the patient was admitted with sepsis and required placement of a 4-lumen, 16cm subclavian central access for vasopressors and anti-arthymics.Within 36 hours of placement, the patient developed skin discoloration at the insertion site.This progressed to tissue breakdown that required surgical debridement and grafting.

Manufacturer Narrative

(b)(4).Device evaluation: the reported complaint could not be confirmed.The customer returned one catheter with evidence of use but no defects or anomalies.The catheter was leak tested with pressurized water and no leaks or crossovers were observed.The appearance of the catheter body indicated the presence of antimicrobial coating.A clinical specialist was consulted and they indicated that the skin discoloration and tissue breakdown was possibly an allergic reaction to the antimicrobial coating.The provided instructions and labels include the contraindication for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or other sulfa drugs.It also warns that if adverse reactions occur after placement, the catheter should be removed immediately.A review of manufacturing records did not yield any relevant findings.Since, no problem was found on the returned sample.No further action will be taken.

• Brand Name: MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 6"
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5063982
• MDR Text Key: 25247400
• Report Number: 1036844-2015-00407
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASK-42854-PMGH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 98