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
Medical Device Problem Codes	Component Missing (2306); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional 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: 04/2024).
Event or Problem Description
It was reported that prior to a port placement procedure for chemotherapy, the packaging was allegedly incomplete.It was further reported that few component were missing.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one slimport titanium implantable port, one catheter, two introducer needles, one hypodermic needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, two catheter locks, one syringe, two guidewires in guidewire hoops, one introducer peel-apart sheath and vessel dilator, one safety infusion set, and one tunneler were returned for evaluation.Visual evaluation was performed on the returned device.Adequate seal transfer was noted on both the inner and outer trays.The investigation is inconclusive for the reported packaging problem and missing component inside the package as the package was returned in opened condition and the exact circumstances at the time of opening the package is unknown.Based upon the available information 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: d4 (expiry date: 04/2024).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 : see h10.
Event or Problem Description
It was reported that prior to a port placement procedure for chemotherapy, the packaging was allegedly incomplete.It was further reported that few component were missing.The procedure was completed using another device.There was no patient contact.

• Brand Name: TITANIUM SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• Common Device Name: 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: 11017090
• Report Number: 3006260740-2020-20930
• Device Sequence Number: 2585975
• Product Code: LJT
• UDI-Device Identifier: 00801741025976
• UDI-Public: (01)00801741025976
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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
• Operator of Device: Health Professional
• Device Model Number: 0605550
• Device Catalogue Number: 0605550
• Device Lot Number: REES3461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other