MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 7 FR. PTFE INTRO KIT; PORT AND CATHETER ACCESSORIES

Model Number	0601170
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 07/2023).
Event or Problem Description
It was reported that during port device implant, the introducer needle allegedly broke in the patient.It was further reported that imaging allegedly identified pneumothorax.Reportedly, the broken part of the needle was removed and intervention was required to remove the port device.The patient was reported as stable.
Event or Problem Description
It was reported that during port device implant, the introducer needle allegedly broke in the patient.It was further reported that imaging allegedly identified pneumothorax.Reportedly, the broken part of the needle was removed and intervention was required to remove the port device.The patient was reported as stable.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was completed, which identified that this is the first complaint reported for this lot number.Therefore, the design history review is not required.Investigation summary: one introducer needle was returned for evaluation.Visual, microscopic and dimensional testing were perform.The needle was broken just distal to the needle hub.The distal needle segment was bent.Blood was noted on the sample.The investigation is confirmed for the alleged breaking of the needle cannula.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.H10: d10, g4 h11: h3, h6 (method 1, results 1, conclusion 1) 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.

• Brand Name: 7 FR. PTFE INTRO KIT
• Common Device Name: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9554252
• Report Number: 3006260740-2019-04072
• Device Sequence Number: 2036266
• Product Code: DYB
• UDI-Device Identifier: 00801741038327
• UDI-Public: (01)00801741038327
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K860432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0601170
• Device Catalogue Number: 0601170
• Device Lot Number: REDU0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 06/11/2020
• 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; Required Intervention