MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNK PORT

Device Problem Inadequate Instructions for Healthcare Professional (1319)

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

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 pending return.

Event Description

It was reported that prior to port placement procedure, the instructions in ifus to use heparin allegedly disagrees with the recommendations of certain authorities.It was further reported that the ifus are allegedly inadequate and should state different instructions.There was no patient contact.

Event Description

It was reported that prior to port placement procedure, the instructions in ifus to use heparin allegedly disagrees with the recommendations of certain authorities.It was further reported that the ifus are allegedly inadequate and should state different instructions.There was no patient contact.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 pending return.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.However, instruction for use for these products were reviewed in edms and it was found that instruction for use are still up to date with ins and ons guidelines and current practice - to flush with saline then heparin for all non-valved ports; proposed practice change - to flush with only normal saline in a pulsatile method.However, these instruction for use are considered adequate because instruction for use were created as per ins and ons guidelines.To date, there is literature that is available that shows safety with the use of saline.Therefore, although the information reported by the customer is included in these instruction for use, the investigation is unconfirmed for the reported issue of labeling inadequacy.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.Instruction for use states: description: "the groshong* catheter may be flushed with normal saline, and it does not require heparin to maintain patency".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.

Event Description

It was reported that prior to port placement procedure, the instructions in ifus to use heparin allegedly disagrees with the recommendations of certain authorities.It was further reported that the ifus are allegedly inadequate and should state different instructions.There was no patient contact.

• Brand Name: UNKNOWN PORT
• 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: 16830669
• MDR Text Key: 314164559
• Report Number: 3006260740-2023-01596
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 08/23/2023; 10/10/2023
• Supplement Dates FDA Received: 08/28/2023; 10/14/2023
• 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