MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG CV CATHETER, SINGLE-LUMEN, 5.5F; CHRONIC CATHETERS

Model Number	7711550
Medical Device Problem Codes	Component Missing (2306); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the groshong 5.5f single-lumen cv catheter that are cleared in the us.The pro code and 510 k number for the groshong 5.5f single-lumen cv catheter are identified.Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.The complaint is confirmed for the identified product identification/marketing information issue, as the investigation confirmed an outdated german brochure, a german website, and certain eu jde german-russian descriptive information incorrectly indicated the device contained an introducer.The marketing team found no other cvc products to be affected.However, the problem has only been discovered in eu jde for 7711550ce at this time.However, the investigation is unconfirmed for the reported issue as no evidence related to missing component issue was found.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.Expiry date: 07/2022.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.Device not returned.
Event or Problem Description
It was reported that during a catheter placement procedure, the skin-separate sheath and the dilator necessary for the implantation of the catheter in the child's vessel are not found.It was further reported that the intervention on children (anesthesia) was prolonged.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: GROSHONG CV CATHETER, SINGLE-LUMEN, 5.5F
• Common Device Name: CHRONIC CATHETERS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15189583
• Report Number: 3006260740-2022-03102
• Device Sequence Number: 14955813
• Product Code: LJS
• UDI-Device Identifier: 00801741036729
• UDI-Public: (01)00801741036729
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2022

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: 7711550
• Device Catalogue Number: 7711550CE
• Device Lot Number: REEU0750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown