MAUDE Adverse Event Report: CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	46100-91
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, testing is not yet complete.
Event or Problem Description
The event involved cath lab w/5 port "off" manifold (600 psi), 72" admin set and 4 ft transpac® iv in which the customer reported, that on an unspecified date, when they connect the fluid line to pressure, the transducer pops off or drips.The connection is loose and will not tighten; the pressures are not accurate.The customer removes the transducer and replaces with a new one that has a shorter cable and they have to cut through the drape and covering with tegaderm.Then patient care resumes.There was no medication involved in this event.There was patient involvement, however, there is no adverse event reported as a consequence this event.
Additional Manufacturer Narrative
One open/unused list #46100-91, cath lab w/5 port "off" manifold (600 psi), 72" admin set and 4 ft transpac® iv; lot #3932045 was returned for evaluation.The reported complaint of connection does not secure is confirmed on the returned set.No visual anomalies were observed.The disconnection was able to be replicated, when the transpac was tightened with hand, the transpac was backing off.A dimensional analysis was conducted on all the female luer tapers of the returned sets.The extreme end female luers of the manifold were found to be out of tolerance.The probable cause for dimensionally failed female luers of the manifold had occurred due to a molding issue.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11744413
• Report Number: 9617594-2021-00140
• Device Sequence Number: 3910946
• Product Code: DQO
• UDI-Device Identifier: 00840619070601
• UDI-Public: (01)00840619070601(17)220101(10)3932045
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K932141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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 Expiration Date: 01/01/2022
• Device Catalogue Number: 46100-91
• Device Lot Number: 3932045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• 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