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
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported "huber needle luer lock hub is cracking.It appears when the adapter is tightened down it cracks the second hub port." 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.A lot history review (lhr) of asfxf020 showed no other similar product complaint(s) from this lot number.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a cracked hub was confirmed; however, the exact cause is unknown.Two photographs of a 20 g powerloc max infusion set with a y-site were returned for evaluation.An initial visual observation of the photographs showed a relatively large longitudinal crack in the y-site of the infusion set.This crack was observed to begin at the proximal end of the y-site and continue through the treading to the middle of the hub, but terminal proximal to the branch in the y-site.No additional damage could be seen on the threads of the y-site.Use residue could be seen on and within the sample in the returned photographs, and the safety mechanism was observed to be engaged over the needle tip.While the exact cause of the crack in the y-site of the sample in the returned photographs could not be determined, possible contributing factors include over-tightening, forceful insertion of a tapered object into the luer hub orifice, and exposure of hub to incompatible chemicals.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "huber needle luer lock hub is cracking.It appears when the adapter is tightened down it cracks the second hub port." no other information was provided.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 1.0 IN
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14519988
• Report Number: 3006260740-2022-01988
• Device Sequence Number: 6551691
• Product Code: FPA
• UDI-Device Identifier: 00801741047350
• UDI-Public: (01)00801741047350
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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 Expiration Date: 10/03/2024
• Device Model Number: N/A
• Device Catalogue Number: 0132010
• Device Lot Number: ASFXF020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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