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

Model Number	1809601
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sometime post port placement procedure, the patient allegedly had pains and spasms in her neck that radiate up into her jaw and tongue.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiration date: 09/2020.
Additional Manufacturer Narrative
H10: additional information was received, there was no problem with the device and hence this record will not be considered as a complaint.However, since an initial mdr was submitted, the file will remain assessed as a malfunction.H10: d4 (expiration date: 09/2020).H11: 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.H3 other text : device not returned.
Event or Problem Description
It was reported that sometime post port placement procedure, the patient allegedly had pains and spasms in her neck that radiate up into her jaw and tongue.There was no reported patient injury.

• 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: 16495788
• Report Number: 3006260740-2023-00694
• Device Sequence Number: 20424699
• Product Code: LJT
• UDI-Device Identifier: 00801741027147
• UDI-Public: (01)00801741027147
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

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 Model Number: 1809601
• Device Catalogue Number: 1809601
• Device Lot Number: RECZ2162
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female