MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TTL1LYR 14FR10ML 100%SIL TMP TRAY

Lot Number 22FBA388

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer contact on (b)(6) it was reported that "foleys had reported leak in balloon and came out with balloon deflated".The patient, an 83 year old male had a foley catheter placed for acute respiratory failure and the catheter was placed while the patient was in the ed, according to the customer contact.The patient was "confused/agitated".On (b)(6), the patient was "restrained bilaterally" and "intubated on (b)(6)".According to the customer contact, after catheter was noticed out of the patient by sicu staff, a second foley catheter was placed.The sample was available and was returned for evaluation however a definitve root cause could not be determined at this time.It has been determined that the reported event could cause or contribute to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Foley catheter balloon deflated causing catheter to come out and additional foley placed.

• Type of Device: TTL1LYR 14FR10ML 100%SIL TMP TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16054197
• MDR Text Key: 306240736
• Report Number: 1417592-2022-00245
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 22FBA388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Date Manufacturer Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other