MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP, PORT ACCESS KIT; PORT ACCESS NEEDLE

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported, patient arrived to outpatient infusion clinic to have their 5-fu pump removed and central venous access site flushed.Patient arrived to infusion suite via ambulation and denied complaints at this time.5fu pump ball appears deflated.Pump disconnected and line flushed with 20ml ns per protocol without incident.While rn attempted to de-access port huber needle; resistance was noted toward the end of the needle and patient verbalized extreme discomfort.Healthcare professional came to chairside to evaluate; per np, "go to the emergency department." patient verbalized understanding and agreed to go to emergency department for further evaluation.Port site + huber needle stabilized with gauze abd dressing + tape.Ed notified via telephone of patient's condition.Patient left infusion suite independently with steady gate.Nurses explained that patient said that he rolled on the needle when sleeping.Came into hospital with the port needle looking to be almost pulled out and experienced intense discomfort when de-accessing.
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 complaint of a damaged needle causing a painful device removal is inconclusive due to the state of the returned sample.One 20 ga x 0.75 in.Safestep infusion set was returned for evaluation.Two photographs were returned for evaluation.An initial visual observation of the returned infusion set showed blood residues throughout the returned device.The safety mechanism was advanced over the needle tip upon the return of the device.The clamp was engaged upon the return of the infusion set.The needle was observed to be bent at a slight angle.A microscopic observation of the needle tip inside the safety mechanism revealed no obvious barbed tip.The safety mechanism could not be removed without further damaging the needle due to the blood residues throughout the device.Because the needle tip did not appeared barbed and no additional significant damage could be observed along the returned device, the complaint of a damaged needle causing a painful device removal is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: SAFESTEP, PORT ACCESS KIT
• Common Device Name: PORT ACCESS NEEDLE
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22677286
• Report Number: 3006260740-2025-05458
• Device Sequence Number: 15740539
• Product Code: FPA
• UDI-Device Identifier: 00801741085529
• UDI-Public: (01)00801741085529(11)250325(17)260731(10)REKP1327
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: PA-0031
• Device Lot Number: REKP1327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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