MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number PR-35052-HPHNM

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports that a call from the ward stated the picc snapped.The patient was having tpn infused via pump, got up to go to the bathroom and on her return the nurse noticed some fluid under the dressing.The dressing was removed and the picc was in two pieces.The patient declined to have another picc inserted.The tpn was ceased and iv cannula inserted to manage iv fluid administration.

Manufacturer Narrative

(b)(4).An arrow 5fr catheter was returned by the customer for evaluation.The catheter showed evidence of use and the catheter body was torn/separated just below the juncture hub.Both sections were returned.Visual examination revealed the catheter body was torn/separated just below the "50" marking.Microscopic examination revealed the ends of the catheter body where torn were jagged and uneven.These jagged edges would indicate a separation related to excessive force.Residual adhesive material was also identified on the catheter body directly next to the separation point.The catheter tear was located 0.7cm from the juncture hub.The separated catheter body measured 49.7cm in length.The two pieces combine to 50.4cm which is within specification.Therefore, no pieces appear to be missing.The catheter outside diameter (od) measured 1.694mm which is also within specification.(con't) other remarks: a device history record (dhr) review was performed on the catheter and no relevant findings were identified.The instruction booklet provided with the set contains the warning not to use scissors to remove dressing in order to reduce the risk of cutting the catheter.It also cautions to check ingredients of prep sprays and swabs before using.Some disinfectants used at catheter insertion site contain solvents which can attack the catheter material.It also warns that not to use alcohol or acetone on catheter surface as these chemicals can weaken the structure of polyurethane materials.The reported complaint of the catheter being torn into two pieces was confirmed by visual examination of the returned sample.The catheter body was separated 0.7cm from the juncture hub.Microscopic examination found the ends of the catheter body to be jagged and uneven indicating that the separation was caused by excessive force placed on the catheter body.The returned catheter met all relevant dimensional specifications.The dhr review performed did not reveal any manufacturing related issues.Based on the investigation findings, it was determined that operational context caused or contributed to this event.

Event Description

The customer reports that a call from the ward stated the picc snapped.The patient was having tpn infused via pump, got up to go to the bathroom and on her return the nurse noticed some fluid under the dressing.The dressing was removed and the picc was in two pieces.The patient declined to have another picc inserted.The tpn was ceased and iv cannula inserted to manage iv fluid administration.

• Brand Name: ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6538504
• MDR Text Key: 74257183
• Report Number: 3003737899-2017-00041
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: 13F15K0238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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