MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported a break at the tubing of the port on a power port.The patient was not harmed, however there was a lot of blood backing up and leaked on the bed.We are monitoring for central line infection.

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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged infusion set was confirmed.The product returned for evaluation was one 20ga x 1¿ powerloc max safety infusion set.Usage residues were observed throughout the sample.A needleless injection cap was attached to the luer adapter and the safety mechanism was engaged.A partially circumferential split was observed at the luer/tubing joint.Microscopic inspection of the split revealed a granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Material buckling and discoloration were observed in the vicinity of the split.The split characteristics and material buckling were consistent with material failure due to repetitive stress.It appeared that the tubing fractured, in part, due to repetitive torsional (twisting) stress; however, an additional unidentified factor(s) also have contributed.The supplier has been notified of this event.A lot history review (lhr) of asfpf085 showed no other similar product complaint(s) from this lot number.H3 other text: evaluation findings are in section h11.

Event Description

It was reported a break at the tubing of the port on a power port.The patient was not harmed, however there was a lot of blood backing up and leaked on the bed.We are monitoring for central line infection.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12542531
• MDR Text Key: 273675090
• Report Number: 3006260740-2021-04029
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047442
• UDI-Public: (01)00801741047442
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0142010
• Device Lot Number: ASFPF085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 09/28/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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