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

Catalog Number 0605300CE

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, the device allegedly had issue with device markings and labelling problem.There was no reported patient injury,.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the titanium implantable port, chronoflex single-lumen, kit, 8f that are cleared in the us.The pro code and 510 k number for the titanium implantable port, chronoflex single-lumen, kit, 8f are identified.As the lot number for the device was not provided, a review of the device history records could not be 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.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium implantable port, chronoflex single-lumen, kit, 8f that are cleared in the us.The pro code and 510 k number for the titanium implantable port, chronoflex single-lumen, kit, 8f are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: although the physical sample was not returned for evaluation, six electronic photos were provided for review.The photos pic 1.Png & pic 3.Png shows a label verification data using a hibc code.The photo pic 2.Png shows a supplier bom sheet where a search of catalog (0605300ce) was found matches with the titanium port 8.0f chrono flex catheter.The photos 3.Png 2.Png & 1.Jpg shows a code 39 barcode (+h3030605300ce0i).For further verification, the labeling team scanned the provided three barcode pictures using a handheld scanner-symbol tech (part number: ls4208-sr20007zzr) and desktop scanner -webscan trucheck omni barcode verifier (part number: model number tc-833).However, the barcodes would not scan from on-screen images with both hand-held scanner and desktop scanner.However, the original labels were not returned for evaluation and only the photos of the barcodes were provided for review which cannot be verified using the handheld or desktop scanners.Based on the poor sample condition, the investigation is inconclusive for the reported incorrect barcode issue.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.H3 other text: device not returned.

Event Description

It was reported that during a port placement procedure, the device allegedly had issue with device markings and labelling problem.There was no reported patient injury.

• Brand Name: TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F
• 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: 14586673
• MDR Text Key: 293252945
• Report Number: 3006260740-2022-02087
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072549
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0605300CE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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