MAUDE Adverse Event Report: COOK INC THAL-QUICK CHEST TUBE SET; GBX CATHETER, IRRIGATION

Model Number	N/A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that the placement of a thal-quick chest tube went well until the last dilator (the biggest dilator) was placed over the guide wire.Customer stated that the dilator looked curved at the tapered portion and the end hole appeared narrow.The tip of the dilator parted (split) during use.It is not known what actions were taken upon noting the issue.There are no reported adverse patient consequences related to this event.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.The device is reportedly available for evaluation; the device has not been received as of this date.
Additional Manufacturer Narrative
A review of documentation, manufacturing instructions, specification and quality control data was conducted during the investigation.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.One used large dilator was returned.There is a noticeable spiral split in the material at the tip of the device.Measurements were taken of the outer diameter, inner diameter and end hole of the dilator and all measurements were found to be within specification.The customer stated that "the dilator looked a little bit curved at the tapered part and the end hole was a bit narrow." this is the second incident reported by this customer for this lot number.The other complaint is 1820334-2017-00548.However, although the end hole of the returned device was found to be on the low end of the specification, there is no indication or definitive evidence that the device was not manufactured to specification.The tip damage may have occurred after the customer tried to place the dilator over the guide wire.Based on the provided information, inspection of returned product and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: THAL-QUICK CHEST TUBE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6420249
• Report Number: 1820334-2017-00543
• Device Sequence Number: 780183
• Product Code: GBX
• UDI-Device Identifier: 00827002048911
• UDI-Public: (01)00827002048911(17)190914(10)7274096
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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): 09/21/2017

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 Model Number: N/A
• Device Catalogue Number: C-TQTS-1600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 84