MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Pain (1994); Chemical Exposure (2570)

Event Date 02/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) review is not possible, as no manufacturing batch number has been provided by the complainant.

Event Description

It was reported by the customer, patient powerloc max has a crack in the distal end (long-end) that had a cap over it.Staff are working to softly loop the tubing to her chest and use an ace wrap to hold it in place (keep in mind she would have this needle, flowed by a male/female equashield safety connector, and the chemo tubing.) additional information received (b)(6) 2023 transparent dressing was used to secure the line.Patient was receiving continuous chemotherapy infusions, incident caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedure to re-access.

Event Description

It was reported by the customer, patient powerloc max has a crack in the distal end (long-end) that had a cap over it.Staff are working to softly loop the tubing to her chest and use an ace wrap to hold it in place (keep in mind she would have this needle, flowed by a male/female equashield safety connector, and the chemo tubing.) additional information received 2/15/2023 transparent dressing was used to secure the line.Patient was receiving continuous chemotherapy infusions, incident caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedure to re-access.Additional information 03/06/2023 it was reported by the customer "leakage was of chemo d545 with 20 kcl, cytarabine, daunorubicin, zofran.".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16483086
• MDR Text Key: 310964316
• Report Number: 3006260740-2023-00674
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047374
• UDI-Public: (01)00801741047374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0132075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR
• Patient Sex: Female
• Patient Weight: 10 KG