MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN TITANIUM PORT S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0606100C

Device Problems Melted (1385); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 01/20/2021

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 not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.The catalog number identified in section d4 has not been cleared in the us but is similar to the hickman titanium port s/l products that are cleared in the us.The pro code and 510 k number for the hickman titanium port s/l products are identified.Expiry date: 03/2022.

Event Description

It was reported that prior to a port placement procedure, the device packing was allegedly found damaged.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the third complaint reported for this product/lot number combination.The device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported packaging damage issue as a crack was noted on the packaging tray in the provided photo.A definitive root cause could not be determined.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: the catalog number identified in section d4 has not been cleared in the us but is similar to the hickman titanium port s/l products that are cleared in the us.The pro code and 510 k number for the hickman titanium port s/l products are identified in d2 and g4.H10: d4 (expiry date: 03/2022).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 Description

It was reported that prior to a port placement procedure, the device packing was allegedly found damaged.There was no reported patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the third complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The investigation is inconclusive for the reported crack in outer tray as the sample was not returned or the provided photo only shows the inner tray of the device.However, the investigation is confirmed for the identified packaging problem and melting issues as a crack was noted on the inner packaging tray in the bottom left corner and the tray appeared melted in different areas in the provided photo.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.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, broviac single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, broviac single-lumen, 6.6f products are identified in d2 and g4.H10: b5, d4 (expiry date: 03/2022), g3, h6 (device, result) 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.Device not returned.

Event Description

It was reported that prior to a port placement procedure, the outer device packing was allegedly found cracked and damaged.There was no patient contact.

• Brand Name: HICKMAN TITANIUM PORT S/L
• 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
• MDR Report Key: 11371326
• MDR Text Key: 234834098
• Report Number: 3006260740-2021-00467
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0606100C
• Device Lot Number: REDS0407
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other