C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 8806060 |
Device Problems
Fracture (1260); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Fitting Problem (2183); Device Damaged Prior to Use (2284); Connection Problem (2900)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/20/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that prior to a port placement procedure via the right subclavian vein, the syringe was allegedly defective and could not be connected to the puncture needle and catheter connector in order to flush the catheter.It was further reported that the syringe was allegedly fractured.The procedure was completed using another device.There was no patient contact.
|
|
Manufacturer Narrative
|
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2022) 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.
|
|
Manufacturer Narrative
|
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device is not returned for evaluation.However, one electronic video was provided for review.The video shows hcp holding an empty syringe, the tip of the syringe is noted to completely broken.Therefore, investigation is confirmed for the reported fracture, connection problem and identified material separation.However, the investigation is kept as inconclusive for the reported device damage prior to use as exact circumstances at the time of reported event is unknown.Therefore, the investigation is confirmed for the reported improper or incorrect procedure or method as expired product was attempted to be used.A definitive root cause could not be determined based upon the provided 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.Instructions for use warns: i.Prior to placement: ¿ examine package carefully before opening to confirm its integrity and that the expiration date has not passed.H10: d4 (expiration date: 03/2022), g3, h6 (method) h11: h6 (device, result, conclusion) 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 prior to a port placement procedure via the right subclavian vein, the syringe was allegedly defective and could not be connected to the puncture needle and catheter connector in order to flush the catheter.It was further reported that the syringe was allegedly fractured.The procedure was completed using another device.There was no patient contact.
|
|
Search Alerts/Recalls
|
|
|