MAUDE Adverse Event Report: ANGIODYNAMICS BIOSTABLE PICC; PERIPHERALLY INSERTED CENTRAL CATHETER,

Catalog Number	H965458320
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported: (photo of defect was provided by the user) the image does show clearly the crack (the syringe is my addition to open up the crack to photo) - i can say that the two luers had devices attached which were both very tightly applied.The attached parts can be seen on image.The report from the medical professional said: cracked picc on lumen used for tpn.5fr picc was inserted for parenteral nutrition on (b)(6) 2019.Day 59 of treatment it was noted that white lumen had visible crack and was leaking.Pn was switched to alternate lumen until picc could be rewired.Picc was successfully rewired on (b)(6) 2019 and faulty picc retained for investigation.Necessitated patient undergoing another procedure to have the picc replaced and delay in patient receiving parenteral nutrition as bag had to be wasted once crack in lumen discovered.No medical intervention required.No patient injury or harm due to this event.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a dual lumen bioflo picc.As received, the catheter was trimmed to approximately 7 cm mark.The returned bioflo picc appeared used.The female luer lock component of the white valve was confirmed to be cracked just adjacent to the parting line.There were no other visual defects noted to the valve or catheter.Reference the attached picture of the cracked hub.An accurate verification/measurement could not be performed for the female taper and threads of the valve due to the crack.The customer's complaint description is confirmed for cracked hub luer.No component molding non-conformances or other damage was observed during visual inspection of the returned sample.The most likely root cause for the cracked female valve housing is due to an over tightened connection with a mating male luer (likely a needleless connector).A contributing factor to the over-tightened connection may be the mechanics/hand placement during infusion access.It is preferable to grasp the needleless connector (nc) when connecting a syringe/tubing to it rather than grasping the pasv valve luer hub while making a connection with the nc.Grasping the pasv valve hub while connecting a syringe/tubing set to the nc can transmit additional torque to the pasv female luer hub.Inadequate flushing of the device lumen may also be a contributing factor.The device history records for the bioflo pasv picc packaging, picc assembly, valve assembly and luer hub molding lots were reviewed for any deviations related to the reported hub crack failure mode.The review confirms that the lots met all material, assembly and performance specifications with no internal non conformance reports (ncr) written.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: BIOSTABLE PICC
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9355765
• Report Number: 1317056-2019-00148
• Device Sequence Number: 2237049
• Product Code: LJS
• UDI-Device Identifier: H965458320
• UDI-Public: H965458320
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: H965458320
• Device Lot Number: 5413454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1