MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607555
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 12/2022).
Event or Problem Description
It was reported that during the port placement procedure, connecter site of port was allegedly broken while connecting catheter.There was no patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The investigation is confirmed for the reported broken connector port issue as the port stem connected with the cath-lock was found completely broken and separated from the port body.Based upon the available information, the definitive root cause for this event is unknown.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: 12/2022), g3, h6 (device, method).H11: b5, h6 (patient, result, conclusion).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 prior to the port placement procedure, connecter site of port was allegedly broken while connecting catheter.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one x-port isp implantable port, one cath-lock, one flushing connector loaded onto one catheter, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, one tunneler and one safety infusion set were returned for evaluation and electronic photo was provided for review.Visual and microscopic visual evaluation were performed on the retuned device.The investigation was confirmed for the reported fracture and material separation as a complete circumferential break was noted to the port stem, the provided photo also confirms the same.The distal part of the broken port stem was connected with cath-lock and a small segment of catheter.The edges of the port stem break was smooth at some region and jagged at some region.Both the break surfaces appeared finely granular.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: 12/2022).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 prior to the port placement procedure, connecter site of port was allegedly broken while connecting catheter.There was no patient contact.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 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
• MDR Report Key: 11782609
• Report Number: 3006260740-2021-01686
• Device Sequence Number: 3722140
• Product Code: LJT
• UDI-Device Identifier: 00801741026201
• UDI-Public: (01)00801741026201
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2021

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: 0607555
• Device Catalogue Number: 0607555
• Device Lot Number: REEW3821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 08/11/2021; 10/05/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 08/13/2021; 10/07/2021
• 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