MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607530
Medical Device Problem Codes	Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 10/2022).Device pending return.
Event or Problem Description
It was reported that during a port placement procedure, the plication of the dilator had problem and not allowing the catheter to descend.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2022).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 or Problem Description
It was reported that during a port placement procedure, the dilator was allegedly difficult to insert, twisted into the patient and kink was noted.It was further reported that the patient experienced pain, traumatized and there was a risk of bleeding.The current status of the patient is unknown.
Event or Problem Description
It was reported that during a port placement procedure, the dilator was allegedly difficult to insert, twisted into the patient and kink was noted.It was further reported that the patient experienced pain, traumatized and there was a risk of bleeding.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one peel-apart sheath with a vessel dilator was returned for evaluation.Visual and microscopic visual evaluation were performed on the returned device.The investigation is confirmed for the reported deformation due to compressive stress issue as a bend was noted on the dilator and tip of the dilator was found deformed.However, the investigation is inconclusive for the reported difficult to insert issue as the exact circumstances at the time of the reported event are unknown and could not be reproduced under laboratory conditions.The definitive root cause could not be determined based upon 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: 10/2022), g3, h6 (patient, method).H11: e3, h6 (result, conclusion).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.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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
• MDR Report Key: 11483336
• Report Number: 3006260740-2021-00834
• Device Sequence Number: 17075032
• Product Code: LJT
• UDI-Device Identifier: 00801741026171
• UDI-Public: (01)00801741026171
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0607530
• Device Catalogue Number: 0607530
• Device Lot Number: REEV0327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 06/09/2021; 09/11/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 07/06/2021; 09/14/2021
• 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