Catalog Number UNKNOWN |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The initial reporter also notified the fda on (b)(6) 2023.Medwatch report # mwref: 23-007.Device expiration date: unknown.Device manufacture date: unknown.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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.
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Event Description
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It was reported that the unspecified bd syringe was noticed to be cracked causing leakage.The following information was provided by the initial reporter: patient found to have blood-saturated linens near broviac central line tubing.Rn clamped central line and assessed line.Rn flushed bifuse attached to lumen backing up blood, noticing where the clave and bifuse lumen were connected was cracked (leaking fluid out).
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Event Description
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It was reported that the unspecified bd syringe was noticed to be cracked causing leakage.The following information was provided by the initial reporter: patient found to have blood-saturated linens near broviac central line tubing.Rn clamped central line and assessed line.Rn flushed bifuse attached to lumen backing up blood, noticing where the clave and bifuse lumen were connected was cracked (leaking fluid out).
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-april-2023.Investigation summary: a device history record review was completed for provided material number 306546 and lot number 2342090.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, one (1) bd syringe was returned for evaluation by our quality team.A lumen connector was also returned; however, no analysis was completed on the connector as it is not a bd product.The syringe was visually inspected and no evidence of defect was identified.An air leakage test was carried out on the syringe and the results were acceptable.Following the air leak test, the luer collar was removed from the top of the syringe and microscopically examined; no signs of defect were identified.Based on the investigation results, no signs of damage or defect were confirmed with the syringe luer component; therefore, a bd manufacturing related cause could not be determined for this reported incident.
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Search Alerts/Recalls
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