MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602230
Medical Device Problem Codes	Fracture (1260); Material Puncture/Hole (1504); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Bruise/Contusion (1754); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of birth: unknown.Medical device expiration date: unknown.Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported unspecified bd lutonix¿ catheter had a hole in the needle hub.The following information was provided by the initial reporter: "when performing the puncture, it was detected presence of air in the syringe in several occasions without achieving the puncture properly.Therefore, it was performed a review of the puncture needle and the syringe, and it was found the needle was broken in its base which represented the air leakage to the syringe.".
Event or Problem Description
It was reported that during a port placement procedure, the needle allegedly leaked air.It was further reported that the needle allegedly broken.Reportedly the patient experienced thoracic bruise and no additional medical intervention was performed to treat the bruise.The procedure was completed by using another device.The patient is reported to be in stable condition.
Additional Manufacturer Narrative
Upon further review, it was identified that the product catalog number belongs to peripheral intervention (pi) - tempe business unit.Therefore, business unit for the complaint has been changed from medication delivery solutions (mds) to peripheral intervention (pi) - tempe.The fda rn number for the mdr 2243072-2022-00133 was inadvertently submitted as 2243072.The correct fda rn number was 3006260740.As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that during a port placement procedure, the needle allegedly leaked air.It was further reported that the needle allegedly broken.Reportedly the patient experienced thoracic bruise and no additional medical intervention was performed to treat the bruise.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: upon further review, it was identified that the product catalog number belongs to peripheral intervention (pi) - tempe business unit.Therefore, business unit for the complaint has been changed from medication delivery solutions (mds) to peripheral intervention (pi) - tempe.The fda rn number for the mdr 2243072-2022-00133 was inadvertently submitted as 2243072.The correct fda rn number was 3006260740.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 sample was not returned for evaluation, one electronic photo was provided for review.The photo shows a needle kept inside a packaging.The investigation is inconclusive for the reported air in device and fracture issue, as no visual anomalies were evident in the provided photo.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.H10: d4 (expiry date: 01/2026), g3, h6 (method).H11: d1, e1(initial reporter city), h6 (result, conclusion).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.H3 other text : device not returned.

• Brand Name: TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city NJ 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas NJ 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13441231
• Report Number: 2243072-2022-00133
• Device Sequence Number: 2160372
• Product Code: LJT
• UDI-Device Identifier: 00801741025563
• UDI-Public: (01)00801741025563
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2022
• 2 Devices were Involved in the Event: 1 2

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: 0602230
• Device Catalogue Number: 0602230
• Device Lot Number: REFR1177
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 02/03/2022; 04/04/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/03/2022; 04/06/2022
• 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 Age: 24 YR
• Patient Sex: Female