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

Model Number 0605550

Device Problems Difficult to Flush (1251); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2025).

Event Description

It was reported that sometimes post port placement procedure, the device allegedly had a twist.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that sometimes post port placement procedure, the device allegedly had a twist.It was further reported that the device allegedly difficulty in flushing.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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 titanium slimport implantable port attached to a catheter in two segments were returned for evaluation.Two complete diagonal breaks were noted on the returned device.However striations were noted on the break surface.Further the catheter was noted to be bent within the cathlock.Therefore, the investigation is confirmed for the identified deformation issue.The investigation is unconfirmed for the material twist issue as no anomalies related to material twist is noted on the returned device.However, the investigation is inconclusive for the reported difficult to flush issue as the exact circumstances at the time of the reported event cannot be verified.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.D4 (expiry date: 05/2025).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.

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 titanium slimport implantable port attached to a catheter in two segments were returned for evaluation.Two complete diagonal breaks were noted on the returned device.However striations were noted on the break surface.Further the catheter was noted to be bent within the cathlock.Therefore, the investigation is confirmed for the reported deformation issue.However, the investigation is inconclusive for the reported difficulty in flushing issue as the exact circumstances at the time of the reported event cannot be verified.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.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 Description

It was reported that sometimes post port placement procedure, the device allegedly folded.It was further reported that the device allegedly had difficulty in flushing.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: TITANIUM SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• Type of Device: 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: 14011986
• MDR Text Key: 288591416
• Report Number: 3006260740-2022-01131
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025976
• UDI-Public: (01)00801741025976
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0605550
• Device Catalogue Number: 0605550
• Device Lot Number: REFV1261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1