MAUDE Adverse Event Report: COOK INC THREE-WAY PLASTIC STOPCOCK; KGZ ACCESSORIES, CATHETER

Catalog Number PTWS-2FLL-MLL-R

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) number: exempt.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during the administration of cancer treatment drug to a female patient of unknown age, a leak was observed from a cook three-way plastic stopcock.The patient did not receive the entire dose of treatment as the result of the leak; however, the patient reportedly experienced no "damage".The physician changed the stopcock to prevent "chemo drug damage to his hands" and the procedure was completed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

D11: concomitant medical products: correction: the chemotherapy drug used in the procedure was adriamycin.Investigation/evaluation: reviews of the complaint history, device history record, documentation, and quality control procedures and a visual inspection and functional test of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed a crack to the stopcock body.A visible red/orange liquid was observed in the device.Additional analysis revealed two ports of the stopcock closed off, and a third port connected to a syringe filled with water.Leak testing confirmed the crack and leakage to the stopcock body.The reported failure mode was able to be recreated.Additionally, a document-based investigation evaluation was performed.This device has been identified to have a nylon core that has the potential to absorb moisture, resulting in increased diameter and potentially cracked stopcock body.As this moisture exposure could have occurred after leaving cook¿s controlled facility, there is no evidence to suggest the product was not made to specifications.A single related complaint from the same production lot was also received and was submitted under emdr#: 1820334-2019-01021.Furthermore, a review of quality control procedures was conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded that the failure mode can be attributed to the design of the device, which is inadequate for the device¿s purpose.Measure are being taken to address this failure mode.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: THREE-WAY PLASTIC STOPCOCK
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8957344
• MDR Text Key: 156585674
• Report Number: 1820334-2019-02190
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)230430(10)8850418
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 8850418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1