MAUDE Adverse Event Report: COOK, INC. FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; KDQ BOTTLE, COLLECTION, VACUUM

Model Number N/A

Device Problems Component(s), broken (1103); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

After inserting the introducer into the baby, the physician tried to withdraw it, leaving the drain in place.However, the physician was unable to do this so he removed the entire device.Upon removal, it was noted that the drain had splintered and a small section was poking through the introducer, explaining why the introducer could not be withdrawn.Additional info provided on the customer complaint from stated: whilst inserting the chest drain dilator over the guidewire, the guidewire fractured and a tiny fibre of wire punctured the dilator making it impossible to withdraw the dilator and leave the guidewire in.The reason only became apparent when the guidewire and dilator were withdrawn.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

(b)(4).Investigation: a review of the complaint history, instructions for use (ifu), quality control (qc) and a visual inspection of the complaint device has been conducted for the purpose of this investigation.The wire guide and dilator were returned in an opened and used condition.A visual inspection noted that the distal end of the 4.5 fr dilator appeared dented.The wire guide had become uncoiled and a stray wire was protruding from the shaft.There is no evidence to suggest that the product was not manufactured to specifications.This product is shipped with an ifu which states under warnings: "the wire guide should always advance without impedance to avoid perforation of any surrounding structures." / "the wire guide should always extend beyond the catheter tip to avoid perforation of any surrounding structures." under instructions for use - step 6: "introduce the wire guide and gently advance it into the selected cavity.Note: the wire guide should advance without impedance." / "remove the needle, leaving the wire guide in place, then dilate with the supplied dilator to facilitate catheter introduction." / "introduce the catheter over the wire guide." we are inconclusive as to why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

After inserting the introducer into the baby, the physician tried to withdraw it, leaving the drain in place.However, the physician was unable to do this so he removed the entire device.Upon removal, it was noted that the drain had splintered and a small section was poking through the introducer, explaining why the introducer could not be withdrawn.Additional information provided on the customer complaint form stated: whilst inserting the chest drain dilator over the guidewire, the guidewire fractured and a tiny fibre of wire punctured the dilator making it impossible to withdraw the dilator and leave the guidewire in.The reason only became apparent when the guidewire and dilator were withdrawn.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
• Type of Device: KDQ BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4254765
• MDR Text Key: 5047335
• Report Number: 1820334-2014-00569
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2017
• Device Model Number: N/A
• Device Catalogue Number: C-PPD-500-WCE-IMH
• Device Lot Number: 4739612
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/14/2014
• Device Age: 10 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 DA