MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Occupation: associate professor of medicine.Pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the wire of a fuhrman pleural/pneumopericardial drainage set "sheared" as it was pulled out of the catheter.The device was being used as a "thoracostomy tube" for a pneumothorax.The (b)(6) male patient was originally admitted for an orthopedic surgical procedure and had a muscular build with no confounding anatomical abnormalities.No difficulty was experienced while inserting the wire.After the shearing of the wire, the use of the complaint device was aborted but the rest of the procedure was completed with a new kit per the "usual routine - bedside, sterile precautions, under local anesthesia and iv narcotics, seldinger technique".This reportedly caused more pain to the patient but no adverse effects.

Manufacturer Narrative

Investigation - evaluation: an issue was reported with a wire guide from a fuhrman pleural/pneumopericardial drainage set (rpn: c-ppd-850-imh) from lot 13106702.Upon removal from the catheter, the wire guide sheared.The procedure was aborted and repeated with a replacement set.No fragments remained in the patient.Cook became aware of this event on 02feb2021 upon being notified by uab.The patient reportedly experienced no adverse effects as a result of this incident.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), quality control, and specifications, as well as a visual inspection, dimensional verification, and functional test of the returned device, was conducted during the investigation.One used wire guide and catheter were returned to cook for evaluation.Upon visual inspection, the anchor solder between the mandril and safety wire was noted to be internally separated, resulting in coil elongation.The solder between the safety wire to the distal solder connection was intact.No damage was noted on the surface of the catheter.A functional test found that a.028" wire was able to advance through the entire length of the catheter.The wire outer diameter was measured at the undamaged section and was found to be within manufacturing tolerance.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (13106702) and the related wire guide subassembly lot revealed a related nonconformance for "kink" in which one device was scrapped, a second related nonconformance for "broken wire" in which one device was scrapped, and a third related nonconformance for "stretched coil" in which one device was scrapped.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document c_t_ppd_rev4 [fuhrman pleural/pneumopericardial drainage set] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿instructions for use: 6.Introduce the wire guide and gently advance it into the selected cavity.Note: the wire guide should advance without impedance.7.Remove the needle, leaving the wire guide in place, then dilate with the supplied dilator to facilitate catheter introduction.8.Introduce the catheter over the wire guide.Note: the wire guide should always extend beyond the catheter tip.9.Advance the catheter into position.Remove the wire guide and attach the multipurpose adapter to the catheter.How supplied upon removal from package, inspect the ensure no damage has occurred.¿ based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause for this event has been traced to a component failure unrelated to a deficiency in manufacturing/device design.It is possible that the wire guide was damaged upon insertion through and contact with the sharp end of the needle, though this cannot be confirmed with certainty.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

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

• Brand Name: FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
• Type of Device: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11308864
• MDR Text Key: 265094662
• Report Number: 1820334-2021-00296
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00827002557239
• UDI-Public: (01)00827002557239(17)230402(10)13106702
• Combination Product (y/n): N
• 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: 06/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2023
• Device Model Number: N/A
• Device Catalogue Number: C-PPD-850-IMH
• Device Lot Number: 13106702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR