C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SINGLE-LUMEN PICC (60CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that "on the morning of (b)(6) 2022 (thursday), the nurse performed catheter puncture on the patient, opened the product package and infiltrated the catheter with nacl, and found that the mark was missing and could not be used normally, and immediately replaced the catheter with a new one.Did not cause any impact on the patient.".
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reez1200 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 "on the morning of february 10, 2022 (thursday), the nurse performed catheter puncture on the patient, opened the product package and infiltrated the catheter with nacl, and found that the mark was missing and could not be used normally, and immediately replaced the catheter with a new one.Did not cause any impact on the patient.".
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Manufacturer Narrative
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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.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the catheter was missing depth markings was confirmed and appears to be related to the manufacturing process.Photographs of sections of the 4fr s/l groshong catheter were returned for evaluation.A series of the depth markers were missing from the catheter.It could not be conclusively determined from the photographs exactly which or how many of the depth markers were missing.However, it should be noted that some of the nearby visible markings were the line markings which occur between 39cm and 59cm.The missing markings were reportedly found prior to implantation and the catheter condition in the photo was consistent with an unused device.It appeared from the photos that the catheter was improperly printed during the manufacturing process.Bd is working closely with manufacturing to help prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported that "on the morning of (b)(6) 2022 (thursday), the nurse performed catheter puncture on the patient, opened the product package and infiltrated the catheter with nacl, and found that the mark was missing and could not be used normally, and immediately replaced the catheter with a new one.Did not cause any impact on the patient.".
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Manufacturer Narrative
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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.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of missing depth markers is confirmed and was determined to be manufacturing related.One 4 fr groshong clearvue catheter with a flushing hub and stiffening stylet inserted and one 4 fr two-piece groshong nxt connector were returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.The printed depth markers between 30 cm and 45 cm we observed to be missing, likely due to improper printing during the manufacturing process.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.
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