MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdrf015 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the tubing cracked at the hub causing leakage.No other information provided.
Event or Problem Description
It was reported that the tubing cracked at the hub causing leakage.No other information provided.(b)(6) 2020 - per air received: patient had port tubing break again - 24 hours after being admitted.This time chemo was infusing.Parents noticed a drop of methotrexate chemo and notified nurse.Nurse stopped chemo.According to nurses, tubing broke above needleless connector.Complainant believes this is the same place it has broken multiple times in the past.Patient had to be de-accessed, re-accessed, blood cultures were draw.Reminder of the chemo tubing was sent back to pharmacy, placed in a new bag and restarted later that day.This may be the 5th time this has happened.Complainant doesn't think there's been any change.The day before, when the patient was admitted, the rn notified the bedside rn about her experiences with the patient's port.Unfortunately, it was a very busy day.Complainant is not sure how the port was taped or if it was taped any differently.Complainant was not providing direct care to the patient.The next day, the complainant reported she happened to walk by right when the patient's port needle had broken so she told the nurse for that day that his has happened before.Complainant states there has not been any change and this happens to the patient every time she is admitted.Complainant states she doesn't think there is anything wrong with the port needle itself; she thinks the patient is so active, the tubing gets pulled/twisted on too much in the same place every time and it just breaks.Complainant suggests some form of communication be given to the nurses to dress and secure the port needle a different way or this will continue to occur.When filing this report, the complainant realized the patient had to be re-accessed twice: once the day after the needle came out and leaked according to the parents, and again two days later when it broke (fda report 3006260740-2020-00293).Tubing ruptured where it inserts into the hard plastic cap.The device leaked and was open to air, putting the patient at risk for bleeding.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdrf015 showed no other similar product complaint(s) from this lot number.
Additional 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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdrf015 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the tubing cracked at the hub causing leakage.No other information provided.(b)(6) 2020 - per air received: patient had port tubing break again - 24 hours after being admitted.This time chemo was infusing.Parents noticed a drop of methotrexate chemo and notified nurse.Nurse stopped chemo.According to nurses, tubing broke above needleless connector.Complainant believes this is the same place it has broken multiple times in the past.Patient had to be de-accessed, re-accessed, blood cultures were draw.Reminder of the chemo tubing was sent back to pharmacy, placed in a new bag and restarted later that day.This may be the 5th time this has happened.Complainant doesn't think there's been any change.The day before, when the patient was admitted, the rn notified the bedside rn about her experiences with the patient's port.Unfortunately, it was a very busy day.Complainant is not sure how the port was taped or if it was taped any differently.Complainant was not providing direct care to the patient.The next day, the complainant reported she happened to walk by right when the patient's port needle had broken so she told the nurse for that day that his has happened before.Complainant states there has not been any change and this happens to the patient every time she is admitted.Complainant states she doesn't think there is anything wrong with the port needle itself; she thinks the patient is so active, the tubing gets pulled/twisted on too much in the same place every time and it just breaks.Complainant suggests some form of communication be given to the nurses to dress and secure the port needle a different way or this will continue to occur.When filing this report, the complainant realized the patient had to be re-accessed twice: once the day after the needle came out and leaked according to the parents, and again two days later when it broke (fda report 3006260740-2020-00293).Tubing ruptured where it inserts into the hard plastic cap.The device leaked and was open to air, putting the patient at risk for bleeding.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9627582
• Report Number: 3006260740-2020-00291
• Device Sequence Number: 18936946
• Product Code: FPA
• UDI-Device Identifier: 00801741047497
• UDI-Public: (01)00801741047497
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020

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 Model Number: N/A
• Device Catalogue Number: 0142275
• Device Lot Number: ASDRF015
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 05/01/2020; 05/20/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 05/19/2020; 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2243072-06/03/2020-006-R
• Patient Sequence Number: 1