MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/22/2024

Event Type  Injury  

Manufacturer Narrative

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.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.

Event Description

It was reported, "i noticed that the needle was missing a small guide part.While removing the dm with guide, after securing it, i noticed that the needle was missing a small part of the guide.Comparing the reported dm with others it was missing a portion.Consequence hospitalization." additional information received 02/08/2024: it was reported, ¿the patient underwent an echo doppler, a visit to the vascular surgery, a chest x-ray and a follow-up echo doppler.The patient was monitored for two days.¿.

Event Description

It was reported, "i noticed that the needle was missing a small guide part.While removing the dm with guide, after securing it, i noticed that the needle was missing a small part of the guide.Comparing the reported dm with others it was missing a portion.Consequence hospitalization." additional information received on 02/08/2024: it was reported, "the patient underwent an echo doppler, a visit to the vascular surgery, a chest x-ray and a follow-up echo doppler.The patient was monitored for two days.".

Manufacturer Narrative

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.The complaint of a damaged guidewire could not be confirmed.The product returned for evaluation was eight (7 sealed and 1 opened) 18g powerglide pro catheter kits.A gross visual inspection and microscopic inspection was conducted on each of the returned units.No damage to any of the components was found on the sealed samples.The green wings on the opened sample were bent upwards.However, no damage to the guidewire or damage to other components was able to be identified on the opened sample.H3 other text: evaluation findings are in section h11.

• Brand Name: 18 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT
• Type of Device: MIDLINE CATHETER
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18764618
• MDR Text Key: 336050968
• Report Number: 3006260740-2024-00692
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6F118100
• Device Lot Number: REHV1176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• 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
• Patient Outcome(s): Required Intervention