BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Catalog Number CK000516 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Chest Pain (1776); Swelling (2091); Anaphylactoid (2218)
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Event Date 12/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebx0748 showed no other similar product complaint(s) from this lot number.Device has not been returned.
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Event Description
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It was reported that as the picc was inserted into patient she developed chest pain, tightness in her throat, and she felt faint.The decision was made to remove picc.It was stated that when dressing the patient¿s arm, multiple hives on arm were noted and extensive swelling to face with hives all over body.The doctor was called and anaphylactic protocol was followed.
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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 reaction could not be confirmed with the evidence provided by the complainant.One 4fr s/l groshong picc was returned for investigation.The catheter was received with the 3cg stylet in the lumen.Evidence of use was observed on the returned sample.The male luer fitting of the t-lock extension set was inserted into the stylet connector, but the threads of the twist cap were not engaged on the stylet connector.Blood residue was visible on the catheter, stylet connector, t-lock extension set, and white insulation on the tether wire.A review of the manufacturing records showed no evidence that the reported event was caused by the manufacturing process.No other similar complaints were reported from this lot.It is possible that the patient had a reaction or sensitivities to the catheter.The ifu states, ¿the potential exists for serious complications including the following: intolerance reaction to implanted device¿.Based on the evidence that was returned for investigation, it could not be confirmed that the returned picc caused the reported reaction.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of rebx0748 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that as the picc was inserted into patient she developed chest pain, tightness in her throat, and she felt faint.The decision was made to remove picc.It was stated that when dressing the patient¿s arm, multiple hives on arm were noted and extensive swelling to face with hives all over body.The doctor was called and anaphylactic protocol was followed.
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Search Alerts/Recalls
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