MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Activation Problem (4042)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 10/07/2023

Event Type  Injury  

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.

Event Description

It was reported by customer that the safety device on the medport was not working.She stated she "had to grab the 2nd set of wings to pull".Stated she had her right hand holding the skin taught and her left hand pulling up from the base of the port and that is when the needlestick occurred.Response received 16 oct 2023, did not involve an urgent/life threatening medical situation, and no patient harm.It did not interrupt the administration of any medication, or cause a clinically significant delay in medication.Patient was not affected except that she had receive post exposure patient testing.While de-accessing the med port the nurse held 2 fingers on each side of the port with her left hand and attempted to pull the need out with her right hand holding on the wings.The needle would not retract and she could not de-access the port using the wings in the normal fashion.After trying a couple of times unsuccessfully, she had to remove the needle by pulling it from the bottom wings (base).As she pulled removed it, the needle scraped her finger, ripping her glove causing an abrasion to her skin.Addt response received 20 oct 2023, patient did not have a bloodborne disease.Clinician was prescribed post exposure prophylaxis meds and tops for 3 days until negative testing completed on patient.The clinician fully recovered.

Event Description

It was reported by customer that the safety device on the medport was not working.She stated she "had to grab the 2nd set of wings to pull".Stated she had her right hand holding the skin taught and her left hand pulling up from the base of the port and that is when the needlestick occurred.Response received 16 oct 2023 did not involve an urgent/life threatening medical situation, and no patient harm.It did not interrupt the administration of any medication, or cause a clinically significant delay in medication.Patient was not affected except that she had receive post exposure patient testing.While de-accessing the med port the nurse held 2 fingers on each side of the port with her left hand and attempted to pull the need out with her right hand holding on the wings.The needle would not retract and she could not de-access the port using the wings in the normal fashion.After trying a couple of times unsuccessfully, she had to remove the needle by pulling it from the bottom wings (base).As she pulled removed it, the needle scraped her finger, ripping her glove causing an abrasion to her skin.Addt response received 20 oct 2023 patient did not have a bloodborne disease.Clinician was prescribed post exposure prophylaxis meds and tops for 3 days until negative testing completed on patient.The clinician fully recovered.

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.

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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of safety mechanism failure to capture the needle tip was inconclusive due to the nature of the provided evidence.The product returned for evaluation was three photographs which depicted a 19ga powerloc safety infusion set.The first two photographs depicted the needle housing, which appeared to be inserted into a piece of furniture.The third photograph depicted the device removed from the furniture.The safety was not advanced and the needle was fully exposed.The safety mechanism was not engaged in the provided photographs; however, safety functionality could not be assessed without examination of the physical sample.Consequently, this complaint is inconclusive at this time.H3 other text: evaluation findings are in section h11.

Event Description

It was reported by customer that the safety device on the medport was not working.She stated she "had to grab the 2nd set of wings to pull".Stated she had her right hand holding the skin taught and her left hand pulling up from the base of the port and that is when the needlestick occurred.Response received on 16 oct 2023: did not involve an urgent/life threatening medical situation, and no patient harm.It did not interrupt the administration of any medication, or cause a clinically significant delay in medication.Patient was not affected except that she had receive post exposure patient testing.While de-accessing the med port the nurse held 2 fingers on each side of the port with her left hand and attempted to pull the need out with her right hand holding on the wings.The needle would not retract and she could not de-access the port using the wings in the normal fashion.After trying a couple of times unsuccessfully, she had to remove the needle by pulling it from the bottom wings (base).As she pulled removed it, the needle scraped her finger, ripping her glove causing an abrasion to her skin.Addl response received on 20 oct 2023: patient did not have a bloodborne disease.Clinician was prescribed post exposure prophylaxis meds and tops for 3 days until negative testing completed on patient.The clinician fully recovered.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18052620
• MDR Text Key: 327125435
• Report Number: 3006260740-2023-04973
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047732
• UDI-Public: (01)00801741047732
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0651934
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White