MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G 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)
Type of Reportable Event	Malfunction
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.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.- attachment: [(b)(4)].
Event or Problem Description
It was reported via medwatch "while administering through the port, leakage was noticed at lower port of the huber needle line.The clave was changed but there was still leakage.Upon closer inspection, a crack was noticed in the lower port of the huber needle set.No lot number available.No leakage prior to this administration.Crack in plastic of lower power.".
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) review is not possible, as no manufacturing lot number has been provided by the complainant.- attachment: [2700040000-2020-8009 rga1592566.Pdf].
Event or Problem Description
It was reported via medwatch "while administering through the port, leakage was noticed at lower port of the huber needle line.The clave was changed but there was still leakage.Upon closer inspection, a crack was noticed in the lower port of the huber needle set.No lot number available.No leakage prior to this administration.Crack in plastic of lower power.".

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 19G 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: 9878947
• Report Number: 3006260740-2020-01015
• Device Sequence Number: 16863402
• Product Code: FPA
• UDI-Device Identifier: 00801741047343
• UDI-Public: (01)00801741047343
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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: 0131975
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 06/18/2020
• 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
• Patient Age: 59 YR