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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PFM MEDICAL, INC. PRIMEPICC; PERIPHERALLY INSERTED CENTRAL CATHETER
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PFM MEDICAL, INC. PRIMEPICC; PERIPHERALLY INSERTED CENTRAL CATHETER Back to Search Results
Model Number PFM2CT4D
Device Problems Crack (1135); Device-Device Incompatibility (2919)
Patient Problem Failure of Implant (1924)
Event Date 11/20/2021
Event Type  malfunction  
Manufacturer Narrative
A device history record (dhr) review was performed and no deviation was found.There is no non-conformance record associated with lot# 2105-036.The raw material r3-0152-01 (4fr x 50 cm dual lumen picc catheter) inspection report is found to be in order.A review of the complaint log showed no similar complaint for ref: pfm2ct4d for the last three years (2018-2020).The complaint product is not available for evaluation at this time.Therefore, the retained sample was inspected and no deviation was found.Further testing was performed with the retained connector using luer torque gauge and it meets the required specification.The supplied valve connectors were connected multiple times to the catheter without any issues.It is possible that the reported crack/leak on the connector can be caused by the over-tightening of the connection during treatment; however, this could not be confirmed pending the final investigation of the complaint product.The ifu indicates that repeated over-tightening of the luer lock connection, syringes, and caps could lead to potential connector failure.In addition, catheter contact with alcohol, acetone, and polyethylene glycol-containing ointments may cause the failure of the device.The root cause cannot be established at this time and will be updated as soon as the product is returned and the investigation is complete.
 
Event Description
4fr dl pfm with clear lumen noted leaking under cap after caps changed.Bedside rn flushed line while vas at bedside with noted leaking under cap.Cap removed with noted crack in clear connector where cap attached.Line clamped and covered.Will require rewire.Team aware.4f dl pfm placed on (b)(6) 2021 in operating room by operating room picc md.4fr dl pfm with clear lumen noted leaking under cap after caps changed; noted crack in clear connector where cap attached will require rewire.(considered adverse event).4f dl pfm exchanged on (b)(6) 2021 by vas picc rn.Pt was discharged from hospital with home care agency involved & dfci out patient; re admitted to hospital.
 
Manufacturer Narrative
A device history record (dhr) review was performed and no deviation was found.There is no non-conformance record associated with lot# 2105-036.The raw material r3-0152-01 (4fr x 50 cm dual lumen picc catheter) inspection report is found to be in order.A review of the complaint log showed no similar complaint for ref: pfm2ct4d for the last three years (2018-2020).The complaint product is not available for evaluation at this time.Therefore, the retained sample was inspected and no deviation was found.Further testing was performed with the retained connector using luer torque gauge and it meets the required specification.The supplied valve connectors were connected multiple times to the catheter without any issues.It is possible that the reported crack/leak on the connector can be caused by the over-tightening of the connection during treatment; however, this could not be confirmed pending the final investigation of the complaint product.The ifu indicates that repeated over-tightening of the luer lock connection, syringes, and caps could lead to potential connector failure.In addition, catheter contact with alcohol, acetone, and polyethylene glycol-containing ointments may cause the failure of the device.The root cause cannot be established at this time and will be updated as soon as the product is returned and the investigation is complete.
 
Event Description
4fr dl pfm with clear lumen noted leaking under cap after caps changed.Bedside rn flushed line while vas at bedside with noted leaking under cap.Cap removed with noted crack in clear connector where cap attached.Line clamped and covered.Will require rewire.Team aware.4f dl pfm placed on (b)(6) 2021 in operating room by operating room picc md.4fr dl pfm with clear lumen noted leaking under cap after caps changed; noted crack in clear connector where cap attached will require rewire.(considered adverse event).4f dl pfm exchanged on (b)(6) 2021 by vas picc rn.Pt was discharged from hospital with home care agency involved & dfci out patient; re admitted to hospital.
 
Manufacturer Narrative
Dhr review: a device history record (dhr) review was performed and no deviation was found.There is no non-conformance record associated with lot# 2105-036.The raw material r3-0152-01 (4fr x 50 cm dual lumen picc catheter) inspection report is found to be in order.A review of the complaint log showed no similar complaint for ref: pfm2ct4d for the last three years (2018-2020).Conclusion: since the complaint product is not available for investigation (product was disposed), the retained sample was inspected and no deviations were found.Further testing was performed with the retain connector using luer torque gauge and it meets the required specification.The valve connectors were also connected multiple times to the catheter without any issues.It is possible that the reported crack/leak on the connector can be caused by the over-tightening of the connection during treatment; however, this could not be confirmed.The ifu indicates that repeated over-tightening of the luer lock connection, syringes, and caps could lead to potential connector failure.In addition, catheter contact with alcohol, acetone, and polyethylene glycol-containing ointments may cause the failure of the device.The root cause is unable to be determined.
 
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Brand Name
PRIMEPICC
Type of Device
PERIPHERALLY INSERTED CENTRAL CATHETER
Manufacturer (Section D)
PFM MEDICAL, INC.
1916 palomar oaks
suite 150
carlsbad CA 92008
Manufacturer (Section G)
PFM MEDICAL, INC.
1916 palomar oaks
suite 150
carlsbad CA 92008
Manufacturer Contact
troy taylor
1916 palomar oaks
suite 150
carlsbad, CA 92008
7607588749
MDR Report Key12983242
MDR Text Key285491820
Report Number2032582-2021-00009
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072391
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/28/2023
Device Model NumberPFM2CT4D
Device Catalogue NumberPFM2CT4D
Device Lot Number2105-036
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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