BARD ACCESS SYSTEMS POWERPICC PROVENA SOLO 5F DL FT MAX BARRIER PLUS KIT W/BIOPATCH, PROBE COVER, &; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 10/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a damaged 3cg stylet was inconclusive because no sample was returned for evaluation.Based on the description of the reported event, possible contributing factors include tensile (pulling) stress, attempted insertion against resistance and inserting the stylet past the tip of the catheter; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.No further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rect2165 showed no other similar product complaint(s) from this lot number.(b)(4).
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Event Description
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It was reported that during placement the tip of the 3cg wire broke off inside the patient.Ir detected it under fluro.Patient transferred to vascular surgeon for removal of 3cg stylet tip.Additional information received from ms&s stated, "from [territory manager's] description of the event it sounded like the inserter hit an obstruction and kept trying to push the picc through the obstruction and then had difficulty removing the picc." additional information stated, "the stylet fragment was removed." on (b)(6) 2018 per medwatch: the patient presented for placement of a picc.Nursing staff reported that during the insertion process, they discovered that a portion of the wire had broken off and remained in the patient.After consultation with radiologist and patient's physician, the decision was made to transfer patient to hospital to have the broken piece of the wire removed.
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