MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET: 16 GA X 27-1/2"; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN032608
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the stopcock was cracked during use, which caused a leak.The device was replaced.No patient harm reported.
Event or Problem Description
It was reported that the stopcock was cracked during use, which caused a leak.The device was replaced.No patient harm reported.
Additional Manufacturer Narrative
Qn#: (b)(4).The customer returned one 3-way stopcock for evaluation.After the stopcock failed functional testing, one large crack was detected on one of the luers.White coloration was observed around the crack, indicating excessive force and/or torqueing caused the damage.The stopcock was functionally tested by attaching each luer to a lab inventory syringe filled with water.When the plunger of the syringe was depressed, water leaked through one large crack of the damaged luer.The other 2 luers functioned as expected.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "the practitioner must be aware of potential air embolism problems associated with leaving open needles or catheters in central venous puncture sites or as a consequence of inadvertent disconnects.To lessen the risk of disconnects, only securely tightened luer-lock connections should be used with this device.Follow hospital protocol to guard against air embolism for all catheter maintenance." the customer report of stopcock leaking during use was confirmed by complaint investigation.The returned stopcock contained one large crack in one of the luers.The crack was consistent with excessive force/torque being used on the luer.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.Based on the sample provided and the customer report that the defect was observed during use, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PICC SET: 16 GA X 27-1/2"
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11896770
• Report Number: 9680794-2021-00244
• Device Sequence Number: 11612923
• Product Code: LJS
• UDI-Device Identifier: 10801902094220
• UDI-Public: 10801902094220
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 07/31/2025
• Device Model Number: IPN032608
• Device Catalogue Number: AJ-01671
• Device Lot Number: 14F20H0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.