MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 2-L 5.5 FR X 50 CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-45052-TG

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

On (b)(6) 2020, a 5.5 french double lumen picc line (cut to 38 cm length) was inserted on a (b)(6) year-old being treated with zosyn, tid, as an outpatient.The insertion was uneventful, easy to advance and had a great blood return to both ports.The patient arrived for an outpatient ct scan yesterday.The radiology team used the picc for iv contrast as is the standard for these pressure rated lines.Immediately on administration of contrast, the patient felt like his upper arm felt tight.Contrast administration was stopped.Pcxr obtained.The anesthesiologist examined the patient, reviewed the chest x-ray and was able to easily remove the line intact.There is an obvious visible fracture at the 5 cm mark.

Manufacturer Narrative

Qn#(b)(4) the customer returned one 2-lumen picc for evaluation.The catheter appeared intentionally truncated and contained signs of use.Visual examination revealed a small hole in the catheter body.The catheter body wall appeared blown out and thinned in appearance, which is consistent with over pressurization the catheter.A kink was also detected adjacent to the juncture hub.The catheter body contained a rupture hole 13-15 mm from the juncture hub.The total length of the catheter body measured to be 15.1875" which indicates at least 4.3125" were trimmed and not returned per product drawing.The outer diameter of the catheter body measured 0.0728", which is within specifications of 0.069"-0.074" per catheter extrusion product drawing.The returned catheter had both lumens flushed.The catheter body only leaked from the identified hole near the juncture hub on the proximal line.The distal extension lines functioned as expected.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user "do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi), to minimize the risk of pressure induced damage to catheter.Catheter clamp must be opened prior to infusion to minimize risk of damage to extension line(s) from excessive pressure.Pressure limit settings on power injector equipment may not prevent over pressurization of an occluded catheter." the customer report of a hole in the catheter body was confirmed by complaint investigation of the returned sample.One hole was found in the body with damage consistent with over pressurization of the catheter.A device history record review was performed with no relevant findings.Based on the condition of the sample received, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

On (b)(6) 2020, a 5.5 french double lumen picc line (cut to 38 cm length) was inserted on a 44-year-old being treated with zosyn tid an outpatient.The insertion was uneventful, easy to advance and had a great blood return to both ports.The patient arrived for an outpatient ct scan yesterday.The radiology team used the picc for iv contrast as is the standard for these pressure rated lines.Immediately on administration of contrast, the patient felt like his upper arm felt tight.Contrast administration was stopped.Pcxr obtained.The anesthesiologist examined the patient, reviewed the chest x-ray and was able to easily remove the line intact.There is an obvious visible fracture at the 5 cm mark.

• Brand Name: ARROW PI PICC KIT: 2-L 5.5 FR X 50 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10453773
• MDR Text Key: 206866836
• Report Number: 1036844-2020-00234
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: ASK-45052-TG
• Device Lot Number: 23F19H0218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR