MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX PORT ACCESS KIT 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2142075
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recr1954 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported the rn noted that blood was on the bed and when she looked closer, she noticed that the line had broken at the part where the line meets up with the clave.It was stated that the patient was put at increased risk of infection.Rn had to deaccess line and re-access it.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded:the complaint of a leak is confirmed and was determined to be use related.One 20 g x 0.75 in.Powerloc max infusion set was returned for evaluation.An initial visual observation showed use residue on and within the returned sample.A microscopic observation revealed a large split in the tubing of the infusion set at the distal end of the luer connector hub.The fracture surfaces were observed to be rough and uneven and exhibited beach marks.Evidence of buckling was observed on the tubing near the fracture site.The location of the split and characteristics of the fracture surface outlined above are typical of damage caused by material fatigue.Material fatigue can occur due to cyclic and/or prolonged kinking/bending of the tubing in which securement, usage, and mechanical factors may gradually form a crack in the tubing.A lot history review (lhr) of recr1954 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The facility reported the rn noted that blood was on the bed and when she looked closer, she noticed that the line had broken at the part where the line meets up with the clave.It was stated that the patient was put at increased risk of infection.Rn had to deaccess line and re-access it.

• Brand Name: POWERLOC MAX PORT ACCESS KIT 20G 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: 7792512
• Report Number: 3006260740-2018-02105
• Device Sequence Number: 186600
• Product Code: FPA
• UDI-Device Identifier: 00801741044298
• UDI-Public: (01)00801741044298
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: 2142075
• Device Catalogue Number: 2142075
• Device Lot Number: RECR1954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1