MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. HARD BASE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0605450
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
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.(expiry date: 04/2021).
Event or Problem Description
It was reported that some time post port placement, the catheter allegedly cracked.There was no reported patient injury.
Event or Problem Description
It was reported that approximately three year six months post port placement, the catheter allegedly cracked.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported catheter fracture as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2021).H11: 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.H3 other text : device not returned.
Event or Problem Description
It was reported that approximately three year six months post port placement, the catheter allegedly cracked.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one catheter segment was returned for evaluation.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the reported catheter fracture as three radially adjacent longitudinal splits were noted approximately 3.5cm from the distal end of the cath-lock.The edges of the radially adjacent longitudinal splits were noted to be smooth in one region and jagged in another.Further during functional evaluation leak was noted from the longitudinal splits upon infusion and air was aspirated during aspiration.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2021), g3.H11: h6 (method, result).H11: 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.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F
• 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
• MDR Report Key: 12097870
• Report Number: 3006260740-2021-02511
• Device Sequence Number: 3713274
• Product Code: LJT
• UDI-Device Identifier: 00801741025945
• UDI-Public: (01)00801741025945
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

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: 0605450
• Device Catalogue Number: 0605450
• Device Lot Number: REBU0493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 08/09/2021; 10/20/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/11/2021; 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR