MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the patient called into the answering service and thinks there is a small leak from the chemo pump.He was asked to come to the ed if he was not able to reach the facility since it is leaking chemo.He called the facility, and they turned it off.He called back and noted a small spill on the chest and his hand from before.No issues on the chest, his hand felt sore, so he put a burn cream on it.I discussed that he can either go to the ed for evaluation or wait for clinic to contact him and arrange for him to come in today for pump evaluation.He said he would rather do the latter since his symptoms are fine.Patient came in and was evaluated by senior nurses in the port lab.Patient is okay.Here is some information i obtained from the clinician about this patient: leakage is occurring either at the upper or lower site of the tubing where it connects to the needle or to the facility tubing.I can confirm we had used a 19g/ 1in needle, unfortunately the nurse accessing this patient's port did not chart the lot number.The leak occurred on the bard port needle in the top lumen where the cap connects.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned.
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.
Event or Problem Description
It was reported the patient called into the answering service and thinks there is a small leak from the chemo pump.He was asked to come to the ed if he was not able to reach the facility since it is leaking chemo.He called the facility, and they turned it off.He called back and noted a small spill on the chest and his hand from before.No issues on the chest, his hand felt sore, so he put a burn cream on it.I discussed that he can either go to the ed for evaluation or wait for clinic to contact him and arrange for him to come in today for pump evaluation.He said he would rather do the latter since his symptoms are fine.Patient came in and was evaluated by senior nurses in the port lab.Patient is okay.Here is some information i obtained from the clinician about this patient: leakage is occurring either at the upper or lower site of the tubing where it connects to the needle or to the facility tubing.I can confirm we had used a 19g/ 1in needle, unfortunately the nurse accessing this patient's port did not chart the lot number.The leak occurred on the port needle in the top lumen where the cap connects.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 1.0 IN
• Common Device Name: 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; parque industrial colonial; salt lake city 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17494845
• Report Number: 3006260740-2023-03436
• Device Sequence Number: 7826776
• Product Code: FPA
• UDI-Device Identifier: 00801741047329
• UDI-Public: (01)00801741047329
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: 0131910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male