MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG CV CATHETER, SINGLE-LUMEN, 8F; CHRONIC CATHETERS

Model Number	7711800
Medical Device Problem Codes	Component Missing (2306); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that upon receiving the package, sterile barrier of the package allegedly breached.There was no patient contact.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that upon receiving the package, sterile barrier of the package allegedly breached.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: one sealed groshong 8 f single-lumen cv catheter kit was returned for evaluation and three electronic photos were provided for review.The investigation is confirmed for the reported tear, rip or hole in device packaging as a small hole is noted on the tyvek lid of the package during sample evaluation and the photo review also confirms the same.Further during photo review the inner cardboard partitions were found missing inside the carton box.However, the investigation is inconclusive for the reported component missing issue as the exact circumstances at the time of the reported events are unknown.The definitive root cause could not be determined based upon 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.D4 (expiry date: 10/2025).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.
Event or Problem Description
It was reported that upon receiving the package, sterile barrier of the package allegedly breached.It was further reported that the component was allegedly missing.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: one sealed groshong 8 f single-lumen cv catheter kit was returned for evaluation and three electronic photos were provided for review.The investigation is confirmed for the reported tear, rip or hole in device packaging as a small hole is noted on the tyvek lid of the package during sample evaluation and the photo review also confirms the same.Further during photo review the inner cardboard partitions were found missing inside the carton box.However, the investigation is inconclusive for the reported component missing issue as the exact circumstances at the time of the reported events are unknown.The definitive root cause could not be determined based upon 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.H10: d4 (expiry date: 10/2025).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.
Event or Problem Description
It was reported that upon receiving the package, sterile barrier of the package allegedly breached.There was no patient contact.

• Brand Name: GROSHONG CV CATHETER, SINGLE-LUMEN, 8F
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11647288
• Report Number: 3006260740-2021-01276
• Device Sequence Number: 3499056
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/07/2021

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: 7711800
• Device Catalogue Number: 7711800
• Device Lot Number: REEY1254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021; 09/29/2021; 12/11/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 08/12/2021; 10/04/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown