MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	6603880
Medical Device Problem Codes	Fluid/Blood Leak (1250); Difficult to Flush (1251); Material Puncture/Hole (1504); Suction Problem (2170); Migration (4003)
Health Effect - Clinical Codes	Extravasation (1842); Unspecified Infection (1930); Pain (1994)
Date of Event	02/13/2014
Type of Reportable Event	Serious Injury
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 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.Device not returned.
Event or Problem Description
It was reported in an article in journal of "burden of complications from needle penetration of plastic ports in children", that the port allegedly had eight occurrences of posterior port perforation and one occurrences of leak, difficult to flush, suction issue and migration was noted.The patient reportedly experienced pain and diagnosed with extravasation and infection.The current status of the patient was unknown.
Additional Manufacturer Narrative
H10: nicole e.Sharp, e.Marty knott, priscilla thomas, douglas c.Rivard and shawn d.St.Peter (2014).Burden of complications from needle penetration of plastic ports in children.Journal of pediatric surgery, 49(5):763-5.Doi: 10.1016/j.Jpedsurg.2014.02.061 h10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.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.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 in an article in journal of "burden of complications from needle penetration of plastic ports in children", that the port allegedly eight occurrences of posterior port perforation and one occurrences of leak, difficult to flush, suction issue and migration was noted.The patient reportedly experienced pain and diagnosed with extravasation and infection.The current status of the patient was unknown.
Event or Problem Description
It was reported in an article in journal of "burden of complications from needle penetration of plastic ports in children", that the port allegedly eight occurrences of posterior port perforation and one occurrences of leak, difficult to flush, suction issue and migration was noted.The patient reportedly experienced pain and diagnosed with extravasation and infection.The current status of the patient was unknown.
Additional Manufacturer Narrative
H10: nicole e.Sharp, e.Marty knott, priscilla thomas, douglas c.Rivard and shawn d.St.Peter (2014).Burden of complications from needle penetration of plastic ports in children.Journal of pediatric surgery, 49(5):763-5.Doi: 10.1016/j.Jpedsurg.2014.02.061 h10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Furthermore, clinical conditions alleged in the complaint cannot be confirmed.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.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.H3 other text : device not returned.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: 13289567
• Report Number: 3006260740-2022-00020
• Device Sequence Number: 4280524
• Product Code: LJT
• UDI-Device Identifier: 00801741027413
• UDI-Public: (01)00801741027413
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2022

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: 6603880
• Device Catalogue Number: 6603880
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 06/07/2022; 06/29/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 06/15/2022; 06/30/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown