MAUDE Adverse Event Report: CRAWFORD INTUB SET .8MMTIP 145MM 544MM; DILATOR, LACHRYMAL

Model Number	MA922R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap that a crawford intubation set (part # ma922r) was used during a meeting with the sales representative to inspect and functionally test the device.According to the complainant, a new device that had been processed was used as an example, and upon pulling the stylet, it detached and the tubing broke.The device was available to be returned to the manufacturer for evaluation.Additional information has been requested, but has not yet been made available.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the lot # of the device in question was not known.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device was performed which revealed that the stylet was not connected to the tubing.Reportedly, the stylet was returned inside the packaging with a label that stated "single use," which was assumed to reference the silicon tubing.The returned tubing was the incorrect size and was found to be thinner and more delicate than the device tubing.The root cause of the reported event was determined to be user error.

• Brand Name: CRAWFORD INTUB SET .8MMTIP 145MM 544MM
• Common Device Name: DILATOR, LACHRYMAL
• MDR Report Key: 11068668
• Report Number: 2916714-2020-00725
• Device Sequence Number: 631352
• Product Code: HNW
• UDI-Device Identifier: 04046964686238
• UDI-Public: 4046964686238
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: MA922R
• Device Catalogue Number: MA922R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/25/2021; 03/04/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/23/2021; 03/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1