MAUDE Adverse Event Report: SALTER LABS PARKER FLEX-TIP (SALTER LABS); ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM

Model Number	I-PFHV-75-10
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, approximately 10 minutes after patient intubation, the anesthesiologist's alarm went off.The endotracheal tube (ett) was replaced with a new one; and an unspecified "non-serious injury" was noted.It was additionally reported, a leak from the base of the pilot balloon was verified, no other problems were reported.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Without a sample to perform functional evaluation the root cause cannot be determined.All information reasonably known as of 26 jun 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
Correction: d4: udi-pi is unavailable as no lot number was provided for the reported incident.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.The complaint was confirmed as reported; however, without a sample to perform functional evaluation the root cause cannot be determined.All information reasonably known as of 26 jun 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sun med holdings llc.Sun med holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sun med holdings complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, approximately 10 minutes after patient intubation, the anesthesiologist's alarm went off.The endotracheal tube (ett) was replaced with a new one; and an unspecified "non-serious injury" was noted.It was additionally reported, a leak from the base of the pilot balloon was verified, no other problems were reported.

• Brand Name: PARKER FLEX-TIP (SALTER LABS)
• Common Device Name: ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids 49544 ; 2054826767
• MDR Report Key: 19620298
• Report Number: 3000219639-2024-00055
• Device Sequence Number: 20441649
• Product Code: BTR
• UDI-Device Identifier: 00607411952746
• UDI-Public: (01)00607411952746
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984528
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: I-PFHV-75-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown