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

Model Number N/A

Device Problems Defective Component (2292); Adverse Event Without Identified Device or Use Problem (2993); Activation Problem (4042)

Patient Problem Pain (1994)

Event Date 08/21/2023

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 device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.H3 other text : device not returned for evaluation.

Event Description

It was reported by customer that they had a defective powerloc needle.The needle was not saved.No patient impact.Additional information received 30 august 2023: upon accessing patient's port with 20g powerloc needle, rn noticed that needle was able to be inserted into patient's port and flushed easily, but patient stated that it hurts slightly.No induration or swelling noted with flushing.Blood return not noted.Rn asked the second rn to assess port for confirmation and again noted that the port flushed without resistance, but the patient still stated that there was still slight pain.Second rn attempted to deaccess patient, but needle would not retract.Therefore, rn had to pull entire needle out and retract needle outside of patient's port.Patient was then reaccessed with new 20g powerloc needle.Port flushed freely without pain.

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.

Event Description

It was reported by customer that they had a defective powerloc needle.The needle was not saved.No patient impact.Additional information received on 30 august 2023: upon accessing patient's port with 20g powerloc needle, rn noticed that needle was able to be inserted into patient's port and flushed easily, but patient stated that it hurts slightly.No induration or swelling noted with flushing.Blood return not noted.Rn asked the second rn to assess port for confirmation and again noted that the port flushed without resistance, but the patient still stated that there was still slight pain.Second rn attempted to deaccess patient, but needle would not retract.Therefore, rn had to pull entire needle out and retract needle outside of patient's port.Patient was then reaccessed with new 20g powerloc needle.Port flushed freely without pain.

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.

Event Description

It was reported by customer that they had a defective powerloc needle.The needle was not saved.No patient impact.Additional information received 30 august 2023: upon accessing patient's port with 20g powerloc needle, rn noticed that needle was able to be inserted into patient's port and flushed easily, but patient stated that it hurts slightly.No induration or swelling noted with flushing.Blood return not noted.Rn asked the second rn to assess port for confirmation and again noted that the port flushed without resistance, but the patient still stated that there was still slight pain.Second rn attempted to deaccess patient, but needle would not retract.Therefore, rn had to pull entire needle out and retract needle outside of patient's port.Patient was then reaccessed with new 20g powerloc needle.Port flushed freely without pain.

• Brand Name: POWERLOC MAX POWER-INJECTIBLE 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 UT 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17741334
• MDR Text Key: 323399547
• Report Number: 3006260740-2023-04077
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047374
• UDI-Public: (01)00801741047374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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: 0132075
• Device Lot Number: ASGXFC074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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