MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G 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)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdtf098 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the tubing cracked at the hub causing leakage.No other information was provided.
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) of asdtf098 showed two other similar product complaint(s) from this lot number.- attachment: [(b)(4) file (b)(4).Pdf].
Event or Problem Description
It was reported that the tubing cracked at the hub causing leakage.No other information was provided.2/19/2020 - medwatch received stated, "port access needle the line broke at where you screw in the connector.".
Event or Problem Description
It was reported that the tubing cracked at the hub causing leakage.No other information was provided.(b)(6) 2020- medwatch received stated, "port access needle the line broke at where you screw in the connector.".
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) of asdtf098 showed two other similar product complaint(s) from this lot number.- attachment: [0533050000-2020-8005 file 1548439.Pdf].

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 22G 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: 9627669
• Report Number: 3006260740-2020-00294
• Device Sequence Number: 19561477
• Product Code: FPA
• UDI-Device Identifier: 00801741047497
• UDI-Public: (01)00801741047497
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020

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: 0142275
• Device Lot Number: ASDTF098
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 02/19/2020; 05/20/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/21/2020; 06/17/2020
• 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: 2 YR