MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT TITANIUM ISP 6CF INT WSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8706060

Device Problems Fluid/Blood Leak (1250); Difficult to Flush (1251); Fracture (1260); Device Damaged Prior to Use (2284)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2024).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 pending return.

Event Description

It was reported that during the preparation of a port placement procedure via right internal jugular vein to right subclavian chest, the accessory syringe puncture needle was allegedly broken while opening the package.There was no patient contact.

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: the sample was not returned for evaluation.Two electronic photos were provided for review.The photo shows a crack on the needle hub.Therefore, the investigation is confirmed for the reported fracture issue.However, the investigation is kept as inconclusive for the reported fluid leak, device damage prior to use and difficult to flush as the provided photo was not sufficient enough to confirm the reported events.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: (expiration date: 04/2024).H11: section a through f ¿ the information provided 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 Description

It was reported that during the preparation of a port placement procedure in the right subclavian chest via the right internal jugular vein, the pink part of the accessory syringe puncture needle was allegedly found to be broken upon opening the package.It was further reported that the port was unable to be pre-flushed and exudate was allegedly found during saline bolus injection.The procedure was completed using another device.There was no patient contact.

• Brand Name: POWERPORT TITANIUM ISP 6CF INT WSP ATT SL
• 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: 18942754
• MDR Text Key: 338487207
• Report Number: 3006260740-2024-01170
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098871
• UDI-Public: (01)00801741098871
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/10/2024

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: 8706060
• Device Lot Number: REGS1965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/02/2024
• 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