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 01/09/2023

Event Type  malfunction  

Event Description

It was reported by the customer, patient powerloc masx 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 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.

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.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported by the customer, patient powerloc masx 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 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: rn called into room by parent for ¿there is blood¿.Upon entering room, blood pooled under patient from port leaking.Upon examining, the longer port hub tubing was cracked and there was blood on patients sheets and actively leaking from cracked line.Patient was receiving continuous chemotherapy infusions during this time, d545 with 20 kcl, cytarabine, daunorubicin, zofran incidence caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedures to reaccess." medwatch received 6/19/2023: "soft tubing just before the proximal port (just before where soft tubing connects to hard plastic) found to have crack noted during infusion.This opened up central line to infection and necessitated needle removal and reinsertion / painful in child.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), complaint history, applicable manufacturing records, sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a crack in the tubing was confirmed and the cause is currently under investigation.The product returned for evaluation was 20g x ¾¿ w/y-site powerloc max infusion set.The returned product sample was evaluated and the following observations were made: a split was observed in the tubing where it connects to the y-site.The fracture surfaces of the damage contained striation-like patterns which were indicative of flexural fatigue-based failures, which may have been a contributing factor to the extension tubing damage.Repetitive mechanical stresses such as twisting and kinking may have contributed to the observed event; however, it appeared that additional unidentified factors also contributed.The device is a supplied component, and the supplier has been notified of this event.

Event Description

It was reported by the customer, patient powerloc masx 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 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: rn called into room by parent for ¿there is blood¿.Upon entering room, blood pooled under patient from port leaking.Upon examining, the longer port hub tubing was cracked and there was blood on patients sheets and actively leaking from cracked line.Patient was receiving continuous chemotherapy infusions during this time, d545 with 20 kcl, cytarabine, daunorubicin, zofran incidence caused a hazardous medication spill (leaking of chemo), delay of treatment, and the need for additional painful procedures to reaccess.".

• 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: 16475638
• MDR Text Key: 310856652
• Report Number: 3006260740-2023-00639
• 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,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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