MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8" (50 CM); CATHETER, INTRAVASCULAR, THER

Model Number IPN033362

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "patient with early insertion of a picc catheter for the management of sedoanalgesia and antibiotics, who is observed leakage of fluid through the walls without apparent cause, when withdrawing by medical order it is evident (catheter completely broken) it is important to clarify that the patient has not had infusions that are considered of high power, nor realization of images" no patient harm was reported.

Manufacturer Narrative

(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a catheter body ruptured was able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "catheter clamp must be opened prior to infusion to minimize risk of damage to extension line(s) from excessive pressure." and "do not exceed the catheter's maximum recommended flow rate located on product labeling." the customer report of a catheter ruptured was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "patient with early insertion of a picc catheter for the management of sedoanalgesia and antibiotics, who is observed leakage of fluid through the walls without apparent cause, when withdrawing by medical order it is evident (catheter completely broken) it is important to clarify that the patient has not had infusions that are considered of high power, nor realization of images" no patient harm was reported.

• Brand Name: ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8" (50 CM)
• Type of Device: CATHETER, INTRAVASCULAR, THER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11942307
• MDR Text Key: 254980748
• Report Number: 9680794-2021-00262
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 10801902095388
• UDI-Public: 10801902095388
• Combination Product (y/n): N
• PMA/PMN Number: K042126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: IPN033362
• Device Catalogue Number: PR-05052-HP
• Device Lot Number: 14F20K0043
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Age: 80 YR