MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.H3 other text : device not returned for evaluation.

Event Description

It was reported by the customer when the infusion port needle was inserted on (b)(6) 2024, the tip of the needle rebounded out of the skin after puncture into the infusion port holder, contaminating the tip of the needle, and the needle was replaced with another infusion port needle for puncture.No other information was provided.

Event Description

It was reported by the customer when the infusion port needle was inserted on (b)(6) 2024, the tip of the needle rebounded out of the skin after puncture into the infusion port holder, contaminating the tip of the needle, and the needle was replaced with another infusion port needle for puncture.No other information was provided.

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 complaint of needle dislodgment is inconclusive due to the state of the returned samples.Two 20 ga x 0.75 in.Powerloc infusion sets were returned for evaluation.An initial visual observation showed some use residues throughout the returned powerloc infusion sets.The safety mechanisms were not advanced over the needle tip upon the return of the devices.A microscopic observation revealed both sample 1 and sample 2 had bent needle tips.Small scratches were observed along the needle shafts of both samples 1 and 2.The distal tip of the needle can become damaged and bent from hitting the back, plastic portion of the port, which in turn may cause the needle to dislodge.The complaint of needle dislodgement during insertion of infusion sets is inconclusive; however, needle insertion techniques may have contributed to the potential observed failure.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 0.75IN
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18961759
• MDR Text Key: 338665889
• Report Number: 3006260740-2024-01236
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741048333
• UDI-Public: (01)00801741048333
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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: 8652034
• Device Lot Number: ASGUFS015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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