MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that a loud "pop" was heard and then there was blood all over the patient's dressing.The port needle tubing had detached from the hub.The port needle was not connected to an infusion when this occurred.Blood ran back into the tube and spilled out.The port had been accessed with this needle for a few days when the event occurred.This was on a port-a-cath, smallest needle size.
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Additional Manufacturer Narrative
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.Based on a review of this information, the following was concluded: the complaint of a tear in the infusion set tubing was confirmed but the cause is unknown.One photo of the implicated powerloc infusion set was provided for investigation.Only the proximal end of a device was visible in the photograph.The visible sections of the device included a portion of the extension tubing and the female luer adapter.It appeared that there was a semi-circumferential split in the tubing, directly distal of the luer adaptor.Microscopic observation and tactile evaluation could not be conducted without receipt of the physical sample.The observable features on the submitted photograph did not contain enough information to identify a specific root cause of the reported event.Possible contributing factors could include tensile (pulling) damage or material fatigue.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that a loud "pop" was heard and then there was blood all over the patient's dressing.The port needle tubing had detached from the hub.The port needle was not connected to an infusion when this occurred.Blood ran back into the tube and spilled out.The port had been accessed with this needle for a few days when the event occurred.This was on a port-a-cath, smallest needle size.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G X 0.75IN
• 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; salt lake city 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17424429
• Report Number: 3006260740-2023-03240
• Device Sequence Number: 5955099
• Product Code: FPA
• UDI-Device Identifier: 00801741047435
• UDI-Public: (01)00801741047435
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2023

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: 0141975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown