MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, KIT, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	1809600
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a port placement procedure, upon opening a power port mri implantable port package, a long hair was allegedly found inside the packaging.A photo of the hair and the product label was provided.There was no patient contact.
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Section a through f ¿ the information provide by bd represents all 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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one partially unsealed power port isp mri implantable port kit was returned for evaluation and two photos were provided for review.Visual evaluation was performed on the returned device.The top tyvek product label was noted to be partially detached from the product tray.Seal transfer was noted throughout the outer tray.A long hair segment was noted on the center portion of the top tyvek label on the product tray when the top tyvek product label was lifted.The hair segment did not move from place.The product tray was noted to be completely sealed.The photo review also confirms reported contamination issue as a long hair segment, was noted on the center portion of the top tyvek label on the product tray.The manufacturing evaluation site states, a closer view revealed the presence of hair contamination within the inner tray, which, according to the information provided, was not adhered to the lid.Therefore, the investigation is confirmed for the reported hair in the package.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d4 (unique identifier (udi) #), e1, g3, h6 (method, result, conclusion) section a through f: the information provided by bd represents all 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 or Problem Description
A patient was prepped for a port placement procedure using power port mri.Prior to the procedure, upon opening a package, a long hair was allegedly found inside the packaging.There was no patient contact.

• Brand Name: POWERPORT M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, KIT, 9.6F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23801455
• Report Number: 3006260740-2025-09651
• Device Sequence Number: 15352453
• Product Code: LJT
• UDI-Device Identifier: 00801741027130
• UDI-Public: (01)00801741027130(11)250416(17)260430(10)REKP0996
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K073423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 04/30/2026
• Device Catalogue Number: 1809600
• Device Lot Number: REKP0996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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
• Patient Sex: Unknown