MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PI MIDLINE 2-L: 5.5FR X 15CM; MIDLINE CATHETER

Catalog Number PR-41552-BAS

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: there seemed to be a small hole in hub area of the catheter, where a high pitch sound could be hear while drawing back or flushing the catheter.

Manufacturer Narrative

(b)(4).The customer returned an agba pi midline 2-l: 5.5fr x 15cm catheter for evaluation.The catheter distal end was cut off and not returned.Visual examination revealed the catheter's distal end appeared to have been intentional cut off and therefore will not be part of this investigation.Visual examination of the catheter revealed an indention in the proximal end of juncture hub.No other defects were found.Functional testing was performed by connecting the extension lines of the catheter to the lab leak tester and clamping off the distal end of the catheter.There should be no liquid leakage from the catheter in the form of a falling drop when tested at 43.5-46.4 psi for 30 sec when tested per bs en iso 10555-1 annex c.The leak tester was turned on and the pressure was increased to 45 psi and held for 30 seconds.No leaks or sounds were observed/heard from any region of the catheter while testing the catheter.The test was performed by additional quality engineer and no issues were observed.A device history record review was performed and no relevant manufacturing issues were identified.The reported complaint of a hole found in the catheter could not be confirmed through visual inspection and functional testing of the returned sample.A molding indention was found in the juncture hub; however, based on teleflex images of the catheter, the indention is supposed to be there.In addition, during functional testing of the returned catheter, there were no leaks observed.No problem found was found with the returned catheter.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: there seemed to be a small hole in hub area of the catheter, where a high pitch sound could be hear while drawing back or flushing the catheter.

• Brand Name: ARROW AGBA PI MIDLINE 2-L: 5.5FR X 15CM
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8633545
• MDR Text Key: 145846376
• Report Number: 9680794-2019-00190
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: PR-41552-BAS
• Device Lot Number: 13F18D0272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1