C.R. BARD, INC. (BASD) -3006260740 TITANIUM IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 0602230 |
Device Problems
Fracture (1260); Material Puncture/Hole (1504); Air/Gas in Device (4062)
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Patient Problems
Bruise/Contusion (1754); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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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.".
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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